Synovo Hip Components

FDA UDI

Class II (US FDA UDI)

by Synovo Production

Identity

Trade Name: SYNOVO HIP COMPONENTS FDA UDI
Generic Name: Ceramic-on-polyethylene total hip prosthesis FDA UDI
Device Name: HIP ACETABULAR BEARING - 47 MM I.D. X 60 MM O.D. FDA UDI
Model / Reference: 01-02-4760 FDA UDI
Description: HIP ACETABULAR BEARING - 47 MM I.D. X 60 MM O.D. FDA UDI

Identifiers

Catalog Number: 01-02-4760 FDA UDI
Primary DI / UDI-DI: 00814193025937 FDA UDI
FDA Product Code: JDI FDA UDI
GMDN Term: Ceramic-on-polyethylene total hip prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3350 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 — 60 Millimeter FDA UDI
Lumen/Inner Diameter — 47 Millimeter FDA UDI

Category: Ceramic-on-polyethylene total hip prosthesis

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

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Also classified as Ceramic-on-polyethylene total hip prosthesis.

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Modal Total Hip System — MODAL MANUFACTURING LLC · Class II
United Hip System, U-Motion II PS Cup, Multi-Hole — UNITED ORTHOPEDIC CORP. · Class II
United Hip System, U-Motion II XPE Cup Liner — UNITED ORTHOPEDIC CORP. · Class II
B-P TOTAL HIP SYSTEM — ENDOTEC, INC. · 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: Synovo Production

Sources (1)

FDA UDI b1ceb4e3-16e7-431f-a303-6704113ae0eb 36 fields · synced Jun 8, 2026