Identity
- Trade Name
- OrthoSolutions 'System26' Bone Screws FDA UDI
- Generic Name
- Surgical implant/trial-implant/sizer holder, reusable FDA UDI
- Device Name
- VARISATION STAPLE HOLDER 90 DEG FDA UDI
- Model / Reference
- OS900092-NS FDA UDI
- Description
- VARISATION STAPLE HOLDER 90 DEG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055662966350 FDA UDI
- 510(k) Number
- K163489 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Surgical implant/trial-implant/sizer holder, 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: Surgical implant/trial-implant/sizer holder, reusable
OrthoSolutions 'System26' Bone Screws by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical implant/trial-implant/sizer holder, reusable.
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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 fba4cb08-5c59-4d4e-9bdc-72959128ffc0 35 fields · synced Jun 8, 2026