Identity
- Trade Name
- FacetLink System FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- MINI Device FDA UDI
- Model / Reference
- 80-1002 FDA UDI
- Description
- MINI Device FDA UDI
Identifiers
- Catalog Number
- 80-1002 FDA UDI
- Primary DI / UDI-DI
- 04026575420919 FDA UDI
- 510(k) Number
- K150223 FDA UDI
- FDA Product Code
- MRW FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- U 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
MR Conditional FDA UDI
Category: Implantable bone washer
FacetLink System by WALDEMAR LINK GmbH & Co. KG — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
- Spiked Gridlock Screw Washer — Trilliant Surgical LLC · Class II
- Monster Screw System — Paragon 28 · Class II
- ALPHALOK Plating System — Vilex, Inc. · Class II
- Monster Screw System — Paragon 28 · Class II
- FLAT WASHER — Biomet Orthopedics, Inc. · Class II
- Fixcet Spinal Facet Screw System — Xtant Medical Holdings, Inc. · U
- LEOS Cannulated Screw System — Tyber Medical · Class II
Cleared under the same submission
K150223 also covers:
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink System — WALDEMAR LINK GmbH & Co. KG
- FacetLink 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 U | Pending data |
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Manufacturer
- Manufacturer
- WALDEMAR LINK GmbH & Co. KG
Sources (1)
- FDA UDI f881e9e5-344c-4b85-87b6-accdd6968a7b 36 fields · synced May 30, 2026