Identity
- Trade Name
- MC-Subtalar™ II FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Device Name
- MC-Subtalar™ II Screw 10 35 T20 stainless steel FDA UDI
- Model / Reference
- 10 35 T20 FDA UDI
- Description
- MC-Subtalar™ II Screw 10 35 T20 stainless steel FDA UDI
Identifiers
- Catalog Number
- FH39351S FDA UDI
- Primary DI / UDI-DI
- 04048266163042 FDA UDI
- 510(k) Number
- K160548 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Subtalar implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDILength — 35 Millimeter FDA UDI
MC-Subtalar™ II by Merete GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 c8bd8d8a-ad63-476c-bde5-085ad8a87777 38 fields · synced May 31, 2026