Identity
- Trade Name
- SideWinder Fracture Plates FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- SideWinder Plate, Lt, 7-Hole, Wide FDA UDI
- Model / Reference
- SWOL-7W FDA UDI
- Description
- SideWinder Plate, Lt, 7-Hole, Wide FDA UDI
Identifiers
- Catalog Number
- SWOL-7W FDA UDI
- Primary DI / UDI-DI
- 00842188101410 FDA UDI
- 510(k) Number
- K060041 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable 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: Orthopaedic fixation plate, non-bioabsorbable
SideWinder Fracture Plates by Trimed, INC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K060041 also covers:
- Calcaneal Plates — Trimed, INC.
- Calcaneal Plates — Trimed, INC.
- Calcaneal Plates — Trimed, INC.
- Calcaneal Plates — Trimed, INC.
- Calcaneal Plates — Trimed, INC.
- Calcaneal Plates — Trimed, INC.
- Calcaneal Plates — Trimed, INC.
- Cancellous Screw 3.8mm — Trimed, INC.
- Cancellous Screw 3.8mm — Trimed, INC.
- Cancellous Screw 3.8mm — Trimed, INC.
- Cancellous Screw 3.8mm — Trimed, INC.
- Cancellous Screw 3.8mm — 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 a20dccd9-79f0-4598-8cfc-b1c79abf65cb 36 fields · synced Jun 1, 2026