Identity
- Trade Name
- Dynamic Syndesmosis FDA UDI
- Generic Name
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- R3ACT Synds Imp 4.2x57mm, 14mm Ntch, St FDA UDI
- Model / Reference
- P80-142-1457-S FDA UDI
- Description
- R3ACT Synds Imp 4.2x57mm, 14mm Ntch, St FDA UDI
Identifiers
- Catalog Number
- P80-142-1457-S FDA UDI
- Primary DI / UDI-DI
- 00889795128669 FDA UDI
- 510(k) Number
- K190365 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile
Dynamic Syndesmosis by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile.
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- ACUMED — ACUMED LLC · Class II
- NCB® — Zimmer, Inc. · Class II
- NCB® — Zimmer, Inc. · Class II
Cleared under the same submission
K190365 also covers:
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
- Baby Gorilla/Gorilla Plating System — Paragon 28
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
- Paragon 28
Sources (1)
- FDA UDI 75461b1f-50cf-4f5a-8b7b-d61131367cc9 35 fields · synced Jun 1, 2026