K2M Patient Specific 111-660BAC

GUDID 10888857548701

Contoured Deformity Rod Size Ø6.0 CoCr

K2M, INC.

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID10888857548701
NIH Device Record Key74edfdcc-1a2b-4da9-bb65-4ccf41a7da2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameK2M Patient Specific
Version Model Number111-660BAC
Catalog Number111-660BAC
Company DUNS146060863
Company NameK2M, INC.
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com
Phone+1(571)919-2000
Emailmark.zellers@stryker.com

Device Dimensions

Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter
Outer Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS110888857548701 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

[10888857548701]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-20
Device Publish Date2022-01-12

On-Brand Devices [K2M Patient Specific]

10888857413054Contoured, Deformity, MESA Rail CoCr
10888857413047Contoured, Deformity, MESA Rail Ti
10888857413030Contoured Deformity Rod, Size Ø5.5 CoCr
10888857413023Contoured Deformity Rod, Size Ø5.5 Ti
10888857548701Contoured Deformity Rod Size Ø6.0 CoCr
10888857548695Contoured Deformity Rod Size Ø6.0 Ti
10888857413269Rod Template
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