Identity
- Trade Name
- DuoMetaCun™ Locking Plate FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- 25 25 FDA UDI
Identifiers
- Catalog Number
- FH06025 FDA UDI
- Primary DI / UDI-DI
- 04048266076434 FDA UDI
- 510(k) Number
- K102688 FDA UDI
- FDA Product Code
- KTT 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
- Not 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
DuoMetaCun™ Locking Plate by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K102688 also covers:
- MetaCun™ II Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
- MetaFix™ Open Wedge Locking Plate — Merete GmbH
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merete GmbH
Sources (1)
- FDA UDI 7ec96f53-cf80-4821-95b8-a5cbc312fc1a 36 fields · synced Jun 6, 2026