Identity
- Trade Name
- NAOS FDA UDI
- Generic Name
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
- Device Name
- NAOS First MPJ Hemi Porous Coated, Ti - M, 20mm FDA UDI
- Model / Reference
- HTR-01-704936 FDA UDI
- Description
- NAOS First MPJ Hemi Porous Coated, Ti - M, 20mm FDA UDI
Identifiers
- Catalog Number
- HTR-01-704936 FDA UDI
- Primary DI / UDI-DI
- 00841742141022 FDA UDI
- 510(k) Number
- K041595 FDA UDI
- FDA Product Code
- KWD FDA UDI
- GMDN Term
- Orthopaedic bone pin, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Orthopaedic bone pin, non-bioabsorbable
The NAOS (Non-Abposable Orthopedic Stabilizer) device is a medical implant used in orthopedic surgery to stabilize bone fractures, grafts, or osteotomies. It features a thin, implantable rod made of non-bioabsorbable material that can be threaded, solid, or semi-flexible, and comes with a break-off shank for improved long-term fixation.
Similar devices
Also classified as Orthopaedic bone pin, non-bioabsorbable.
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- KW03-310-18.A — newbox medical GmbH · Class IIb
- Steinmann Pins, K-Wire, smooth — Gebr. Brasseler GmbH & Co. KG · Class II
- IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
- XtraFix® External Fixation System — Zimmer, Inc. · Class II
- CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
- TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
- SMART TSF — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K041595 also covers:
- 5-Star Template — BIOPRO, INC.
- CHISEL — BIOPRO, INC.
- FIRST MPJ HEMI COMPLETE KIT — BIOPRO, INC.
- First MPJ Instrument Tray — BIOPRO, INC.
- Impactor Tip LG — BIOPRO, INC.
- LESSER MPJ TRIAL 10.25MM — BIOPRO, INC.
- LESSER MPJ TRIAL 11.0MM — BIOPRO, INC.
- LESSER MPJ TRIAL 14.00MM — BIOPRO, INC.
- MPJ TRIAL 17mm (SM) — BIOPRO, INC.
- MPJ TRIAL 20mm (MD) — BIOPRO, INC.
- MPJ TRIAL 21.5mm (ML) — BIOPRO, INC.
- MPJ Trial 21.5mm (ML) — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Hnm Total Recon Llc
Sources (1)
- FDA UDI 7b55e7fd-213c-4603-8861-fc9a605c93c5 35 fields · synced Jul 20, 2026