Identity
- Trade Name
- Vilex Implant Accessory FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Washer, 6.5mm Ti Screws .468x.275x.040 FDA UDI
- Model / Reference
- 635-65T FDA UDI
- Description
- Washer, 6.5mm Ti Screws .468x.275x.040 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841731114846 FDA UDI
- 510(k) Number
- K991151 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Implantable bone washer
Vilex Implant Accessory by Vilex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Implantable bone washer.
- ISOLA — Depuy Spine, Inc. · Class II
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- 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
- FacetLink System — WALDEMAR LINK GmbH & Co. KG · U
Cleared under the same submission
K991151 also covers:
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
- Vilex Lag Screw — Vilex, Inc.
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
- Vilex, Inc.
Sources (1)
- FDA UDI f1aea37f-18f2-4b13-9060-c1bfc2da14db 34 fields · synced May 30, 2026