Identity
- Trade Name
- Corifix Ligament Anchor Screw FDA UDI
- Generic Name
- Ligament bone anchor FDA UDI
- Device Name
- LIGAMENT ANCHOR FDA UDI
- Model / Reference
- 165.015 FDA UDI
- Description
- LIGAMENT ANCHOR FDA UDI
Identifiers
- Catalog Number
- 165.015 FDA UDI
- Primary DI / UDI-DI
- 05055196994492 FDA UDI
- 510(k) Number
- K973005 FDA UDI
- FDA Product Code
- HWC 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
Yes
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
Radiation Sterilization FDA UDI
Category: Ligament bone anchor
Corifix Ligament Anchor Screw by Corin Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ligament bone anchor.
- EZLOC — Biomet Sports Medicine · Class II
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- 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
- TITANIUM INTERFERENCE SCREW — Biomet Sports Medicine · Class II
Cleared under the same submission
K973005 also covers:
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
- Corifix Ligament Anchor Screw — CORIN LTD
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Corin Ltd
Sources (1)
- FDA UDI a53d45ec-a2eb-4a59-bfe3-94584274e8ab 36 fields · synced Jun 1, 2026