Identity
- Trade Name
- Abutment replica FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- to be used together with the Impression coping and Guide pins to get the exact position of the actual abutments when making a cast of the prosthesis site FDA UDI
- Model / Reference
- 90374 FDA UDI
- Description
- to be used together with the Impression coping and Guide pins to get the exact position of the actual abutments when making a cast of the prosthesis site FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09321502063401 FDA UDI
- 510(k) Number
- K945154 FDA UDI
- FDA Product Code
- FZE FDA UDI
- GMDN Term
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3680 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
Category: General external orthopaedic fixation system implantation kit, reusable
Abutment replica by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General external orthopaedic fixation system implantation kit, reusable.
- GPC — Gpc Medical, Ltd. · Class I
- GPC — Gpc Medical, Ltd. · Class I
- GPC — Gpc Medical, Ltd. · Class I
- GPC — Gpc Medical, Ltd. · Class I
- Zavation SCREW TO SCREW COMPRESSOR — ZAVATION · Class II
- GPC — Gpc Medical, Ltd. · Class I
- Cross Element Guide Sleeve — TOBY ORTHOPAEDICS · Class I
- GPC — Gpc Medical, Ltd. · Class I
Cleared under the same submission
K945154 also covers:
- Abutment replica for Vistafix VXA300 — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
- Baha — Cochlear Bone Anchored Solutions AB
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
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 6b50d753-78a3-41c6-9964-c246f4b48017 36 fields · synced May 30, 2026