Identity
- Trade Name
- Ø4.0mm DISTAL DRILL GUIDE, LOCKING FDA UDI
- Generic Name
- Surgical drill guide, reusable FDA UDI
- Model / Reference
- 0315-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665001440 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Surgical drill guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3020 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 drill guide, reusable
Ø4.0mm DISTAL DRILL GUIDE, LOCKING by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K021008 also covers:
- ADJUSTABLE STOP — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTI-ROTATION SCREW 5.0mm x 95mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CORTICAL SCREW 5.0mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL 11mm x 20cm x 125° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL 11mm x 20cm x 135° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL 12mm x 20cm x 125° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL, LEFT 11mm x 36cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL, LEFT 12.5mm x 45cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS TROCHANTERIC NAIL, RIGHT 10mm x 36cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
K070444 also covers:
- ANTI-ROTATION AND DISTAL SHEATH, LOCKING — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED BLOCKING SCREW 5.0mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CANNULATED BLOCKING SCREW 5.0mm x 85mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 20.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 22.5mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 45.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 55.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 60.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 70.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 4.2mm x 85.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 110mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
K123569 also covers:
- AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 44cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 32cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 48cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 48cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 38cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 42cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 30cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 34cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
K132005 also covers:
- AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 140mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 30mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 115mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 120mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 45mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 50mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 40mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 70mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 80mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW 5.0mm x 90mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 55mm — 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 5e618975-5733-4589-b779-5079f5caaf45 34 fields · synced May 30, 2026