Foot Plates

FDA UDI

Class II (US FDA UDI)

by Trimed, INC.

Identity

Trade Name: Foot Plates FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: H-Plate, Short, 2.7mm FDA UDI
Model / Reference: HP27-S FDA UDI
Description: H-Plate, Short, 2.7mm FDA UDI

Identifiers

Catalog Number: HP27-S FDA UDI
Primary DI / UDI-DI: 00842188100550 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

The Foot Plates are a non-bioabsorbable, implantable sheet designed to stabilize fractured orthopaedic bones, fuse joints, and facilitate osteotomy repairs. These orthopaedic fixation plates are intended for use in conjunction with other implants and instruments, making them suitable for complex surgical procedures.

Similar devices

Also classified as Orthopaedic fixation plate, non-bioabsorbable.

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AXSOS — Stryker Corp. · Class II
Xpert Wrist — NEWCLIP TECHNICS · Class II
ACUMED — ACUMED LLC · Class II
Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

Cleared under the same submission

K050681 also covers:

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: Trimed, INC.

Sources (1)

FDA UDI 3d269790-9fc3-455e-ac57-21af99d441aa 36 fields · synced Jul 8, 2026