Identity
- Trade Name
- ACUMED FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- 2.7mm X 25mm Self Drilling Pin FDA UDI
- Model / Reference
- FX-4054-S FDA UDI
- Description
- 2.7mm X 25mm Self Drilling Pin FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10806378067594 FDA UDI
- 510(k) Number
- K965029 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Acumed by Acumed Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- CASCADIA™ Interbody System — K2M, INC. · Class II
Cleared under the same submission
K965029 also covers:
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
- Acumed Llc
Sources (1)
- FDA UDI f73c2521-3617-4ab9-834e-eb4d689721e5 35 fields · synced Jun 8, 2026