Identity
- Trade Name
- LACTOSCREW FDA UDI
- Generic Name
- Tendon/ligament bone anchor, bioabsorbable FDA UDI
- Model / Reference
- 905581 FDA UDI
Identifiers
- Catalog Number
- 905581 FDA UDI
- Primary DI / UDI-DI
- 00880304453401 FDA UDI
- FDA Product Code
- JDR FDA UDIHWC FDA UDIMBI FDA UDIMAI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, 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: Tendon/ligament bone anchor, bioabsorbable
Lactoscrew by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tendon/ligament bone anchor, bioabsorbable.
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Cleared under the same submission
K033355 also covers:
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.
- ALLthread PEEK-OPTIMA — Biomet Orthopedics, Inc.
- HITCH L15 — Biomet Orthopedics, Inc.
- Hitch L15 — 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI f86e99c2-442a-4a1a-a7c6-f9499c29993d 36 fields · synced Jun 6, 2026