Identity
- Trade Name
- Fortis ACP FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Fortis Fixed Angle Screw (Self_Tapping Rounded Tip) (L1)14x(L2)16.9x(D)4.5mm-Gold #61 FDA UDI
- Model / Reference
- A FDA UDI
- Description
- Fortis Fixed Angle Screw (Self_Tapping Rounded Tip) (L1)14x(L2)16.9x(D)4.5mm-Gold #61 FDA UDI
Identifiers
- Catalog Number
- TP.FTR.4513 FDA UDI
- Primary DI / UDI-DI
- 08800113935556 FDA UDI
- 510(k) Number
- K173099 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable 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
Yes
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: Spinal fixation plate, non-bioabsorbable
Fortis ACP by Dio Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal fixation plate, non-bioabsorbable.
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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 fd94ae6c-9ddc-4947-8b01-2f87713cf7ed 36 fields · synced Jun 8, 2026