Identity
- Trade Name
- Focus TyPEEK FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- Focus TyPEEK 26mm x 10mm x 12mm x 8 ° FDA UDI
- Model / Reference
- SV2612L FDA UDI
- Description
- Focus TyPEEK 26mm x 10mm x 12mm x 8 ° FDA UDI
Identifiers
- Catalog Number
- SV2612L FDA UDI
- Primary DI / UDI-DI
- M695SV2612L0 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 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: Metal-polymer composite spinal interbody fusion cage
Focus TyPEEK by Tyber Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MIDLINE II-Ti — Centinel Spine, LLC · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
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
- Tyber Medical
Sources (1)
- FDA UDI 5cec13e6-df65-46c8-890c-23e0d8796273 35 fields · synced Jun 8, 2026