Identity
- Trade Name
- Washers FDA UDI
- Generic Name
- Implantable bone washer FDA UDI
- Device Name
- Washer, 2.4 Screw FDA UDI
- Model / Reference
- WASHR-2.4 FDA UDI
- Description
- Washer, 2.4 Screw FDA UDI
Identifiers
- Catalog Number
- WASHR-2.4 FDA UDI
- Primary DI / UDI-DI
- 00842188125362 FDA UDI
- 510(k) Number
- K222637 FDA UDI
- FDA Product Code
- NDG FDA UDI
- GMDN Term
- Implantable bone washer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Category: Implantable bone washer
Washers by Trimed, INC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Implantable bone washer.
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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
Cleared under the same submission
K222637 also covers:
- Hex Cortical Screw 3.2mm — Trimed, INC.
- Hex Cortical Screw 3.2mm — Trimed, INC.
- Hex Cortical Screw 3.2mm — Trimed, INC.
- Hex Cortical Screw 3.2mm — Trimed, INC.
- Hex Cortical Screw 3.2mm — Trimed, INC.
- Hex Cortical Screw 3.2mm — Trimed, INC.
- Hook Plates — Trimed, INC.
- Hook Plates — Trimed, INC.
- Locking HEX Screw 3.2mm — Trimed, INC.
- Locking HEX Screw 3.2mm — Trimed, INC.
- Locking HEX Screw 3.2mm — Trimed, INC.
- Locking HEX Screw 3.2mm — Trimed, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trimed, INC.
Sources (1)
- FDA UDI f5725f49-96c5-4b2c-9463-a897eb278088 36 fields · synced May 30, 2026