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Reduction Bolt, Tibial Insertion Guide, Suprapatellar
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- REDUCTION BOLT, TIBIAL INSERTION GUIDE, SUPRAPATELLAR FDA UDI
- Generic Name
- Bone-nailing compression screw FDA UDI
- Model / Reference
- 1257-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665036657 FDA UDI
- 510(k) Number
- K070444 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Bone-nailing compression screw 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: Bone-nailing compression screw
Reduction Bolt, Tibial Insertion Guide, Suprapatellar by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Bone-nailing compression screw.
- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
- 3.0mm Compression Tool — INTERVENTIONAL SPINE, INC · Class I
- OIC Cannulated Screw System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- ELOS INSTRUMENTS — INTRAUMA SPA · Class II
- Compressor — Orthopedic Designs North America, Inc. · Class I
- Compression Tool with Tray — INTERVENTIONAL SPINE, INC · Class I
- Dyna Locking Trochanteric Nail — CG MedTech Co., Ltd. · Class I
- SLX System Compression Tool — INTERVENTIONAL SPINE, INC · Class I
Cleared under the same submission
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.
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 |
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Manufacturer
- Manufacturer
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI fe4d996d-d254-456f-85e3-376b484d4184 34 fields · synced May 30, 2026