Identity
- Trade Name
- ALLTHREAD KNOTLESS PEEK-OPTIMA FDA UDI
- Generic Name
- Bone tap, reusable FDA UDI
- Model / Reference
- 904840P FDA UDI
Identifiers
- Catalog Number
- 904840P FDA UDI
- Primary DI / UDI-DI
- 00880304476639 FDA UDI
- FDA Product Code
- MAI FDA UDIHWC FDA UDIJDR FDA UDIMBI FDA UDI
- GMDN Term
- Bone tap, reusable 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Bone tap, reusable
Allthread Knotless Peek-Optima by Biomet Sports Medicine — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone tap, reusable.
- BIOSURE — Smith & Nephew, Inc. · Class I
- NobelActive® — Nobel Biocare AG · Class I
- CORTICAL TAP — Biomet Orthopedics, Inc. · Class I
- PressON™ — NEXUS SPINE, L.L.C. · Class I
- Insite — TORNIER, INC. · Class I
- ReLine — Nuvasive, Inc. · Class I
- Mariner MIS — SeaSpine Orthopedics Corporation · Class I
- Response 5.5/6.0 Spine System — ORTHOPEDIATRICS CORP. · Class I
Cleared under the same submission
K060693 also covers:
K070389 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Sports Medicine
Sources (1)
- FDA UDI 96ddefc0-62cf-4903-9e5c-1b4a70d3c840 36 fields · synced May 30, 2026