Identity
- Trade Name
- ALLthread PEEK-OPTIMA FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Model / Reference
- 904930P FDA UDI
Identifiers
- Catalog Number
- 904930P FDA UDI
- Primary DI / UDI-DI
- 00880304644588 FDA UDI
- 510(k) Number
- K080088 FDA UDI
- FDA Product Code
- MBI FDA UDIMAI FDA UDIHWC FDA UDIJDR FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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: Tendon/ligament bone anchor, non-bioabsorbable
ALLthread PEEK-OPTIMA by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080088 also covers:
- ALLTHREAD LACTOSORB — Biomet Orthopedics, Inc.
- ALLTHREAD LACTOSORB — Biomet Orthopedics, Inc.
- ALLTHREAD LACTOSORB — Biomet Orthopedics, Inc.
- ALLTHREAD LACTOSORB — Biomet Orthopedics, Inc.
- ALLTHREAD LACTOSORB — Biomet Orthopedics, Inc.
- ALLTHREAD LACTOSORB — Biomet Orthopedics, Inc.
- ALLTHREAD TITANIUM — Biomet Orthopedics, Inc.
- ALLthread PEEK-OPTIMA — Biomet Orthopedics, Inc.
- ALLthread PEEK-OPTIMA — Biomet Orthopedics, Inc.
- HITCH L15 — Biomet Orthopedics, Inc.
- Hitch L15 — Biomet Orthopedics, Inc.
- Hitch Suture Anchor — Biomet Orthopedics, Inc.
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
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 3c223c54-2fd4-46a0-af3f-329ccac8d701 36 fields · synced May 30, 2026