Dhs

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: DHS FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: 150 DEG DHS® PLATE-STANDARD BARREL 8 HOLES/142MM FDA UDI
Model / Reference: 281.480 FDA UDI
Description: 150 DEG DHS® PLATE-STANDARD BARREL 8 HOLES/142MM FDA UDI

Identifiers

Catalog Number: 281480 FDA UDI
Primary DI / UDI-DI: 10886982177421 FDA UDI
510(k) Number: K791619 FDA UDI
FDA Product Code: KTT FDA UDI
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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Dhs by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K791619 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: Synthes

Sources (1)

FDA UDI f9d4b318-61e1-4f1a-8c1e-8d0bb66feb6f 36 fields · synced May 31, 2026