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S-Rom

FDA UDI

Class III (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name
S-ROM FDA UDI
Generic Name
Uncoated hip femur prosthesis, modular FDA UDI
Device Name
S-ROM Total Hip System FEMORAL STEM Right XXLong 36+21 CR NECK +8 11/13 TAPER 20x15x325 Lateral FDA UDI
Model / Reference
56-3060R FDA UDI
Description
S-ROM Total Hip System FEMORAL STEM Right XXLong 36+21 CR NECK +8 11/13 TAPER 20x15x325 Lateral FDA UDI

Identifiers

Catalog Number
563060R FDA UDI
Primary DI / UDI-DI
10603295177715 FDA UDI
FDA Product Code
MRA FDA UDI
MEH FDA UDI
LZO FDA UDI
LWJ FDA UDI
LPH FDA UDI
JDI FDA UDI
GMDN Term
Uncoated hip femur prosthesis, modular FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
888.3353 FDA UDI
888.3360 FDA UDI
888.3358 FDA UDI
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

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Uncoated hip femur prosthesis, modular

S-Rom by Depuy Orthopaedics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated hip femur prosthesis, modular.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy Orthopaedics, Inc.

Sources (1)

  • FDA UDI a744eb11-beac-40f7-88b0-09a279ad8f30 35 fields · synced Jun 8, 2026