Identity
- Trade Name
- AOS CORTICAL SCREW 2.7mm x 32mm FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Model / Reference
- 8036-032 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665023930 FDA UDI
- 510(k) Number
- K103513 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
AOS CORTICAL SCREW 2.7mm x 32mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, non-sterile.
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- Monster Screw System — Paragon 28 · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
- TMS SYSTEM — BIOMET MICROFIXATION, INC · Class II
- Flow-Screw™ — Flow-Fx, LLC · Class II
Cleared under the same submission
K103513 also covers:
- AOS ANTERIOR CLAVICLE PLATE 10-HOLE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTERIOR CLAVICLE PLATE 9-HOLE — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 16mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 22mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 26mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 32mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 34mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 38mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANCELLOUS LAG SCREW 4.0mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CORTICAL LOCKING SCREW 2.7mm x 12mm — 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 e64c7385-8166-4c96-9a19-a0be88b85608 33 fields · synced May 30, 2026