Identity
- Trade Name
- Footmotion Plating System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- FLTDV0-ST FDA UDI
Identifiers
- Catalog Number
- FLTDV0-ST FDA UDI
- Primary DI / UDI-DI
- 03700569637590 FDA UDI
- 510(k) Number
- K221395 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Orthopaedic fixation plate, non-bioabsorbable
The Footmotion Plating System is a non-bioabsorbable, implantable sheet designed to stabilize fractured orthopaedic bones, fuse joints (arthrodesis), or facilitate osteotomies. This device is intended for use in conjunction with other fixation plates and instruments. The Footmotion system offers flexibility, simplicity, and ease of use, making it an attractive option for medical professionals.
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- ACUMED — ACUMED LLC · Class II
- Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
- osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II
Cleared under the same submission
K221395 also covers:
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
- Footmotion Plating System — NEWCLIP TECHNICS
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Newclip Technics
Sources (1)
- FDA UDI f8712a96-8bcc-45b8-b675-f4de39c2df46 34 fields · synced Jul 19, 2026