Identity
- Trade Name
- PROXIMAL TIBIAL INSTRUMENT TRAY FDA UDI
- Generic Name
- Surgical instrument/implant rack FDA UDI
- Model / Reference
- 9956-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665032147 FDA UDI
- 510(k) Number
- K202489 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Surgical instrument/implant rack FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical instrument/implant rack
Proximal Tibial Instrument Tray by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/implant rack.
- MOBIO™ Total Knee System — b-ONE Ortho Corp. · Class I
- VASSOIO GAMMAFIX DOI ROSA — MEDESY srl · Class I
- LOQTEQ® — aap Implantate AG · Class I
- 1208 — Siam intermagnate CO.,LTD. · Class I
- VASSOIO GAMMAFIX CINC AZZURRO — MEDESY srl · Class I
- Accessories, arthroscopic — PARCUS MEDICAL LLC · Class I
- SPIRECUT — Spirecut AG · Class I
- MATRIXWAVE — Synthes · Class I
Cleared under the same submission
K202489 also covers:
- 5.0mm HEX DRIVER, AO STYLE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 10mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 14mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 16mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 26mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 28mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 42mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- DIAMOND WORKHORSE SCREW™, Ø3.5mm x 48mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
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
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 0b51eaa3-cd79-44f1-86ca-dcce027a4896 34 fields · synced May 31, 2026