AlternatiV+ Max Knotless Anchor 20KPN4751

GUDID 00850005827382

4.75MM MAX KNOTLESS ANCHOR

Genesis Biologics, Inc.

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID00850005827382
NIH Device Record Key28fd6c1b-92cb-466d-8811-6e079e44fa3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlternatiV+ Max Knotless Anchor
Version Model Number20KPN4751
Catalog Number20KPN4751
Company DUNS016463487
Company NameGenesis Biologics, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone657-888-6243
EmailORDERS@GENESISBIOLOGICS.COM

Device Dimensions

Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005827382 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-16
Device Publish Date2024-10-08

Devices Manufactured by Genesis Biologics, Inc.

00850005827368 - AlternatiV+ Screw-In Anchor2024-10-16 4.75MM SCREW-IN SUTURE ANCHOR
00850005827375 - AlternatiV+ Screw-In Anchor2024-10-16 5.5MM SCREW-IN SUTURE ANCHOR
00850005827382 - AlternatiV+ Max Knotless Anchor2024-10-164.75MM MAX KNOTLESS ANCHOR
00850005827382 - AlternatiV+ Max Knotless Anchor2024-10-16 4.75MM MAX KNOTLESS ANCHOR
00850005827399 - DUAL PITCH AWL/TAPPER 4.75MM2024-10-16 DUAL PITCH AWL/TAPPER 4.75MM
00850005827405 - DUAL PITCH AWL/TAPPER 5.5MM2024-10-16 DUAL PITCH AWL/TAPPER 5.5MM
00850005827412 - AWL/TAPPER 4.5MM2024-10-16 AWL/TAPPER 4.5MM
00850005827429 - AWL 4.5MM2024-10-16 AWL 4.5MM
00850005827436 - AWL 5.5MM2024-10-16 AWL 5.5MM
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.