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VersiTomic® G-Lok with 45mm Loop
FDA UDIClass II (US FDA UDI)
by T.a.g Medical Products Agricultural Cooperative Association
Identity
- Trade Name
- VersiTomic® G-Lok with 45mm Loop FDA UDI
- Generic Name
- Ligament bone anchor FDA UDI
- Model / Reference
- F FDA UDI
Identifiers
- Catalog Number
- tg101045st FDA UDI
- Primary DI / UDI-DI
- 10810190010102 FDA UDI
- 510(k) Number
- K101616 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Ligament bone anchor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ligament bone anchor
VersiTomic® G-Lok with 45mm Loop by T.a.g Medical Products Agricultural Cooperative Association — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Ligament bone anchor.
- EZLOC — Biomet Sports Medicine · Class II
- MINI BONE MULCH — Biomet Sports Medicine · Class II
- EZLOC™ — Biomet Orthopedics, Inc. · Class II
- JUGGERKNOT — Biomet Orthopedics, Inc. · Class II
- M-ARS ACL: Anatomic Ribbon Surgery System — Medacta International · Class II
- TITANIUM INTERFERENCE SCREW — Biomet Sports Medicine · Class II
- AXL CROSSPIN — Biomet Sports Medicine · Class II
- Corifix Ligament Anchor Screw — CORIN LTD · Class II
Cleared under the same submission
K101616 also covers:
- ProCinch, Slotted Button, Concave Round 11mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- ProCinch, Slotted Button, Concave Round 14mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- ProCinch, Slotted Button, Concave Round 20mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- ProCinch, Slotted Button, Flat 14mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- ProCinch, Slotted Button, Flat 8 X 12mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok XL — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok with 15mm Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok with 20mm Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok with 25mm Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok with 30mm Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok with 35mm Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
- VersiTomic® G-Lok with 40mm Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 914bcc12-0cbe-4fd0-a6d8-f841f2c5fd34 34 fields · synced Jun 1, 2026