K2™ Hemi Toe Implant System 201010

GUDID M2482010101

The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted into the medullary canal of the phalanx. It is indicated for use in patients with osteoarthritis of the first metatarsophalangeal joint, trauma involving the first metatarsophalangeal joint, hallux rigidus with degenerative joint disease or arthritis.

INTEGRA LIFESCIENCES CORPORATION

Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis Partial metatarsophalangeal joint prosthesis
Primary Device IDM2482010101
NIH Device Record Key2b073997-a7f3-4bb3-a735-a23044966560
Commercial Distribution StatusIn Commercial Distribution
Brand NameK2™ Hemi Toe Implant System
Version Model Number201010
Catalog Number201010
Company DUNS963856096
Company NameINTEGRA LIFESCIENCES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780065548 [Primary]
HIBCCM2482010101 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWDProsthesis, Toe, Hemi-, Phalangeal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-02-26
Device Publish Date2017-10-09

On-Brand Devices [K2™ Hemi Toe Implant System]

M2482032001K2 HEMI REAMER
M2482050021K2 HEMI BASE
M2482050011K2 HEMI LID
M2482050001K2 HEMI TRAY
M248201040KMI1The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
M2482010301The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
M2482010201The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
M2482010101The K2 Hemi Toe implant is intended for cement fixation by means of a stem, which is inserted in
M24820310041K2™ Hemi Toe Implant System TOE PLATE
M2482030201K2 HEMI SHAPER SIZE 2
M24820310051K2 HEMI GUIDE SCREW
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