Epi-Union

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: EPI-UNION FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: Tibial Plate;proximal-lateral;left FDA UDI
Model / Reference: 1275-02-10 FDA UDI
Description: Tibial Plate;proximal-lateral;left FDA UDI

Identifiers

Catalog Number: 1275-02-10 FDA UDI
Primary DI / UDI-DI: 07613327094060 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 201.0 Millimeter FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Epi-Union by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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
osteo-WEDGE2 12 Degree Angulated Bone Plate Implant, Large — Gramedica · Class II

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: Stryker Corp.

Sources (1)

FDA UDI a056cbe9-3a3a-4e27-a15f-87328e4a312b 35 fields · synced Jun 1, 2026