Identity
- Trade Name
- Versalock Upper Limb Plating System FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Versalock Hook Clavicle Plate Right 9.0mm 11 Holes 2.7/3.5mm FDA UDI
- Model / Reference
- Versalock Hook Clavicle Plate Right 9.0mm 11 Holes 2.7/3.5mm FDA UDI
- Description
- Versalock Hook Clavicle Plate Right 9.0mm 11 Holes 2.7/3.5mm FDA UDI
Identifiers
- Catalog Number
- 343-50-11D-09 FDA UDI
- Primary DI / UDI-DI
- 07899258664521 FDA UDI
- 510(k) Number
- K243740 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 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
Category: Orthopaedic fixation plate, non-bioabsorbable
Versalock Upper Limb Plating System by Gm Dos Reis Industria E Comercio Ltda — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K243740 also covers:
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Mini and Micro Fragments Reconstruction System - GMReis — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Versalock Upper Limb Plating System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Versalock Upper Limb Plating System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Versalock Upper Limb Plating System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
- Versalock Upper Limb Plating System — GM DOS REIS INDUSTRIA E COMERCIO LTDA
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
- Gm Dos Reis Industria E Comercio Ltda
Sources (1)
- FDA UDI fa11d96d-fd97-48dc-b6d3-61158169ac17 35 fields · synced Jun 1, 2026