Identity
- Trade Name
- MP Reconstruction Prosthesis FDA UDI
- Generic Name
- Sleeve femoral/tibial extension, uncoated FDA UDI
- Device Name
- Proximal Spacer FDA UDI
- Model / Reference
- 172-950/20 FDA UDI
- Description
- Proximal Spacer FDA UDI
Identifiers
- Catalog Number
- 172-950/20 FDA UDI
- Primary DI / UDI-DI
- 04026575203079 FDA UDI
- 510(k) Number
- K142187 FDA UDI
- FDA Product Code
- LZO FDA UDILWJ FDA UDIJDI FDA UDI
- GMDN Term
- Sleeve femoral/tibial extension, uncoated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 FDA UDI888.3360 FDA UDI888.3350 FDA UDI
- Commercial Distribution
- 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
Category: Sleeve femoral/tibial extension, uncoated
MP Reconstruction Prosthesis by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sleeve femoral/tibial extension, uncoated.
- Pantheon System — ADLER ORTHO SPA · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
- Tibial Stem Extension Reamer — TOTAL JOINT ORTHOPEDICS, INC. · Class I
- Pantheon System — ADLER ORTHO SPA · Class II
- Pantheon System — ADLER ORTHO SPA · Class II
- MUTARS® extension piece — implantcast GmbH · Class II
- MUTARS® connecting part — implantcast GmbH · Class II
- REDAPT — Smith & Nephew, Inc. · Class II
Cleared under the same submission
K142187 also covers:
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
- MP Reconstruction Prosthesis — WALDEMAR LINK GmbH & Co. KG
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
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI d2910ed0-c19d-4a7b-acd5-bca8ce0f63af 36 fields · synced Jun 7, 2026