Identity
- Trade Name
- osseolink Implant FDA UDI
- Generic Name
- Orthopaedic implant driver FDA UDI
- Device Name
- Universal Implant Driver FDA UDI
- Model / Reference
- UID FDA UDI
- Description
- Universal Implant Driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816273020696 FDA UDI
- 510(k) Number
- K091878 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Orthopaedic implant driver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 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
Radiation Sterilization FDA UDI
MR Safe FDA UDI
Category: Orthopaedic implant driver
osseolink Implant by Osseolink Usa Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091878 also covers:
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
- osseolink Implant — OSSEOLINK USA LLC
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
- Osseolink Usa Llc
Sources (1)
- FDA UDI b24379c3-768b-4c60-af45-14c563470a0f 36 fields · synced May 30, 2026