Identity
- Trade Name
- Fortis ACP FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
- Device Name
- Fixed-angle screws (self-tapping) D4 x L10 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Fixed-angle screws (self-tapping) D4 x L10 FDA UDI
Identifiers
- Catalog Number
- TP.FTA.4010 FDA UDI
- Primary DI / UDI-DI
- 08800039829250 FDA UDI
- 510(k) Number
- K173099 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile
Fortis ACP by Dio Medical Co., Ltd. — 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
- AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- APTUS — Medartis Inc. · Class II
- SMOOTH PEG — Biomet Orthopedics, Inc. · Class II
- AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 105mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
- QWIX — Newdeal Sas · Class II
- Monster Screw System — Paragon 28 · Class II
Cleared under the same submission
K173099 also covers:
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
- Fortis ACP — Dio Medical Co., Ltd.
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
- Dio Medical Co., Ltd.
Sources (1)
- FDA UDI 794e347e-1cfa-4987-8304-ad31c572f9d0 36 fields · synced May 30, 2026