Identity
- Trade Name
- Foot Plates FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Straight Plate, 6-Hole, 2.7mm FDA UDI
- Model / Reference
- SP27-6 FDA UDI
- Description
- Straight Plate, 6-Hole, 2.7mm FDA UDI
Identifiers
- Catalog Number
- SP27-6 FDA UDI
- Primary DI / UDI-DI
- 00842188100666 FDA UDI
- 510(k) Number
- K050681 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
Foot Plates by Trimed, INC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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Cleared under the same submission
K050681 also covers:
- 2.3 Cortical Screw — Trimed, INC.
- 2.3 Cortical Screw — Trimed, INC.
- 2.3 VA Locking Screw — Trimed, INC.
- 2.3 VA Locking Screw — Trimed, INC.
- 2.3 VA Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 2.7 Locking Screw — Trimed, INC.
- 3.5 Locking Screw — Trimed, INC.
- 3.5 Locking Screw — 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 acb645e2-5a9a-4f90-b880-45c08a12b763 36 fields · synced Jun 1, 2026