Identity
- Trade Name
- CoLink® NeoFuse FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Anterior Fusion Plate, 5-Hole, Right FDA UDI
- Model / Reference
- P20 ST125 FDA UDI
- Description
- Anterior Fusion Plate, 5-Hole, Right FDA UDI
Identifiers
- Catalog Number
- P20 ST125 FDA UDI
- Primary DI / UDI-DI
- 00810021864389 FDA UDI
- 510(k) Number
- K213069 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
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
Category: Orthopaedic fixation plate, non-bioabsorbable
CoLink® NeoFuse by In2Bones, USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K213069 also covers:
- CoLink — In2Bones, USA
- CoLink — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- CoLink® NeoFuse — In2Bones, USA
- In2Bones — In2Bones, USA
- In2Bones — In2Bones, USA
- In2Bones — In2Bones, USA
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
- In2Bones, USA
Sources (1)
- FDA UDI 35f8347f-35db-4e1e-b351-155e377ba7b2 36 fields · synced May 30, 2026