Identity
- Trade Name
- COLS® FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Model / Reference
- 266140 - PEEK SCREW, Ø10 / L25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489661402 FDA UDI
- 510(k) Number
- K113591 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable 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
Yes
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
Yes
FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Cols® by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
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- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
K113591 also covers:
- Angulated awl — FOURNITURES HOSPITALIERES INDUSTRIE
- BROCHE 25CM 2, 4MM BOUT MECHE BOUT ROND (Teknomedical) — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- COLS® — FOURNITURES HOSPITALIERES INDUSTRIE
- Cannulated reamer Diameter 4, 5 — FOURNITURES HOSPITALIERES INDUSTRIE
- Chopping block — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS 2.4mm guide pin Lg 250mm Soft/drill — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS ACL femoral point to point guide V2 — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS ACL tibial point to point guide V2 — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS Bone Tap — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS Open Tendon Stripper — FOURNITURES HOSPITALIERES INDUSTRIE
- CoLS PCL femoral guide V5 — FOURNITURES HOSPITALIERES INDUSTRIE
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
- Manufacturer
- Fournitures Hospitalieres Industrie
Sources (1)
- FDA UDI 5a1877ba-1e2c-41ca-bc76-9883b76bec8e 33 fields · synced May 30, 2026