Identity
- Trade Name
- Locking Plates FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Device Name
- Locking Plate, Straight, 8-Hole FDA UDI
- Model / Reference
- PS8 FDA UDI
- Description
- Locking Plate, Straight, 8-Hole FDA UDI
Identifiers
- Catalog Number
- PS8 FDA UDI
- Primary DI / UDI-DI
- 00842188100840 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
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Orthopaedic fixation plate, non-bioabsorbable
Unlock the power of Locking Plates, a non-bioabsorbable orthopaedic fixation plate designed to stabilize fractured bones in both adults and children. Our Straight, 8-Hole plates are perfect for treating traumatic/pathological fractures, joint fusion (arthrodesis), or osteotomy repairs. With a firm construction and screw attachment mechanism, Locking Plates provide long-lasting stability and are ideal for use with other fixation devices.
Similar devices
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
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 5553f936-20c2-46bd-9f31-e5fab58ce9ba 36 fields · synced Jul 21, 2026