Synovo Hip Components

FDA UDI

Class II (US FDA UDI)

by Synovo Production

Identity

Trade Name: SYNOVO HIP COMPONENTS FDA UDI
Generic Name: Resurfacing metallic hip prosthesis FDA UDI
Device Name: HIP FEMORAL RESURFACING CUP - 38MM FDA UDI
Model / Reference: 01-03-0038 FDA UDI
Description: HIP FEMORAL RESURFACING CUP - 38MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00814193025739 FDA UDI
510(k) Number: K904870 FDA UDI
FDA Product Code: KXA FDA UDI
GMDN Term: Resurfacing metallic hip prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3400 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

Dimensions & Sizes

Size: Outer Diameter — 38 Millimeter FDA UDI

Category: Resurfacing metallic hip prosthesis

Synovo Hip Components by Synovo Production — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Synovo Production

Sources (1)

FDA UDI 5dc92296-e034-4611-9f40-745f8bdbf8eb 36 fields · synced May 30, 2026