Identity
- Trade Name
- Impression coping squared for Vistafix VXA300 FDA UDI
- Generic Name
- General external orthopaedic fixation system implantation kit, reusable FDA UDI
- Device Name
- to be used as a temporary abutment template that shall be attached to an abutment to get the exact reference point of the actual abutment when making an impression of the prosthesis site FDA UDI
- Model / Reference
- 93192 FDA UDI
- Description
- to be used as a temporary abutment template that shall be attached to an abutment to get the exact reference point of the actual abutment when making an impression of the prosthesis site FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09321502063371 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
Impression coping squared for Vistafix VXA300 by Cochlear Bone Anchored Solutions AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General external orthopaedic fixation system implantation kit, reusable.
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Cleared under the same submission
K945154 also covers:
- Abutment replica — Cochlear Bone Anchored Solutions AB
- 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
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
- Cochlear Bone Anchored Solutions AB
Sources (1)
- FDA UDI 3661b11c-802f-4257-b349-8858489561e2 36 fields · synced May 31, 2026