Identity
- Trade Name
- Megasystem C FDA UDI
- Generic Name
- Diaphysis prosthesis FDA UDI
- Device Name
- Stem Components,Push-through, for total femur replacement FDA UDI
- Model / Reference
- 15-8522/70 FDA UDI
- Description
- Stem Components,Push-through, for total femur replacement FDA UDI
Identifiers
- Catalog Number
- 15-8522/70 FDA UDI
- Primary DI / UDI-DI
- 04026575383399 FDA UDI
- 510(k) Number
- K151008 FDA UDI
- FDA Product Code
- LWJ FDA UDIJDI FDA UDILZO FDA UDIKRO FDA UDI
- GMDN Term
- Diaphysis prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3360 FDA UDI888.3350 FDA UDI888.3353 FDA UDI888.3510 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: Diaphysis prosthesis
Megasystem C by WALDEMAR LINK GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diaphysis prosthesis.
- ORTHOPEDIC SALVAGE SYSTEM (OSS) — Biomet Orthopedics, Inc. · Class II
- OsteoBridge™ Interlocking Screw — Merete GmbH · Class II
- OsteoBridge™ IDSF Diaphysis Humeral Nail — Merete GmbH · Class II
- OsteoBridge™ IDSF Diaphysis Tibial Nail — Merete GmbH · Class I
- OsteoBridge™ — Merete GmbH · Class I
- OsteoBridge™ IDSF Diaphysis Femoral Spacer — Merete GmbH · Class II
- OsteoBridge™ IDSF Diaphysis Tibial Nail — Merete GmbH · Class II
- OsteoBridge™ IDSF Diaphysis Femoral Nail — Merete GmbH · Class II
Cleared under the same submission
K151008 also covers:
- Endo Model Knee Fusion Nail FK — WALDEMAR LINK GmbH & Co. KG
- Endo Model Knee Fusion Nail FK — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG
- Endo-Model SL Knee Prosthesis System — 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 abaf15d9-ce0b-4357-a52c-0aee560416ec 36 fields · synced May 30, 2026