Identity
- Trade Name
- CoLink Mfx FDA UDI
- Generic Name
- Orthopaedic bur, reusable FDA UDI
- Device Name
- Lisfranc Drill, Ø2.7 mm, Cannulated, Sterile, Single-Use FDA UDI
- Model / Reference
- C02 S0081 FDA UDI
- Description
- Lisfranc Drill, Ø2.7 mm, Cannulated, Sterile, Single-Use FDA UDI
Identifiers
- Catalog Number
- C02 S0081 FDA UDI
- Primary DI / UDI-DI
- 00810021866413 FDA UDI
- 510(k) Number
- K210060 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic bur, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bur, reusable
CoLink Mfx by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bur, reusable.
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Midas Rex Clearview™ — MEDTRONIC XOMED, INC. · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- Uniglide Unicondylar Knee Prosthesis — CORIN LTD · Class II
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
- KOMET Surgical Bur — Gebr. Brasseler GmbH & Co. KG · Class I
Cleared under the same submission
K210060 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- In2Bones, USA
Sources (1)
- FDA UDI ed158dcb-4aef-4eea-b1dc-adc766a9fa1f 36 fields · synced Jun 1, 2026