Identity
- Trade Name
- Nakoma FDA UDI
- Generic Name
- Orthopaedic fixation implant alignment tool FDA UDI
- Device Name
- Fixation Pin Instrument FDA UDI
- Model / Reference
- 3100T-1300 FDA UDI
- Description
- Fixation Pin Instrument FDA UDI
Identifiers
- Catalog Number
- 3100T-1300 FDA UDI
- Primary DI / UDI-DI
- M6863100T13000 FDA UDI
- 510(k) Number
- K141993 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic fixation implant alignment tool FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic fixation implant alignment tool
Nakoma by Alliance Partners Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation implant alignment tool.
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Cleared under the same submission
K141993 also covers:
- Nakoma — ALLIANCE PARTNERS LLC
- Nakoma — ALLIANCE PARTNERS LLC
- Nakoma — ALLIANCE PARTNERS LLC
- Nakoma — ALLIANCE PARTNERS LLC
- Nakoma — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS LLC
- Nakoma ACP System — ALLIANCE PARTNERS 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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Alliance Partners Llc
Sources (1)
- FDA UDI a0b6b67a-55c0-443e-a0cb-a3fc9c6b4ce8 36 fields · synced Jun 8, 2026