Identity
- Trade Name
- OrthoSolutions 'System26' Bone Screws FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Device Name
- POWER ADAPTOR JACOBS QC FDA UDI
- Model / Reference
- OS900073-NS FDA UDI
- Description
- POWER ADAPTOR JACOBS QC FDA UDI
Identifiers
- Catalog Number
- OS900073-NS FDA UDI
- Primary DI / UDI-DI
- 05055662956634 FDA UDI
- 510(k) Number
- K163489 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable 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
No
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 implant-instrument extension adaptor, reusable
OrthoSolutions 'System26' Bone Screws by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
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- ACS® — implantcast GmbH · Class I
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- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
Cleared under the same submission
K163489 also covers:
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
- OrthoSolutions 'System26' Bone Screws — ORTHO SOLUTIONS HOLDINGS LIMITED
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 |
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Manufacturer
- Manufacturer
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI 43029b05-8d57-4bd3-b145-a702d7d6af84 36 fields · synced Jun 8, 2026