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: 135 DEG DHS PLATE-STD BARREL 20 HOLES/333MM-STERILE FDA UDI
Model / Reference: 281.020S FDA UDI
Description: 135 DEG DHS PLATE-STD BARREL 20 HOLES/333MM-STERILE FDA UDI

Identifiers

Catalog Number: 281020S FDA UDI
Primary DI / UDI-DI: 10886982176455 FDA UDI
510(k) Number: K791619 FDA UDI
FDA Product Code: JDO FDA UDI
KTT 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

Yes

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

Yes

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 6425e0d3-e46e-42fa-ba7a-4907945e5810 36 fields · synced May 31, 2026