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Inhance

FDA UDI

Class II (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
INHANCE FDA UDI
Generic Name
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI
Device Name
INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID SMALL Ø24mm CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY FDA UDI
Model / Reference
5100-24-022 FDA UDI
Description
INHANCE SHOULDER SYSTEM HYBRID UNITI GLENOID SMALL Ø24mm CEMENTED CAUTION: INTENDED FOR CEMENTED USE ONLY FDA UDI

Identifiers

Catalog Number
510024022 FDA UDI
Primary DI / UDI-DI
10603295549161 FDA UDI
510(k) Number
K212933 FDA UDI
FDA Product Code
MBF FDA UDI
KWT FDA UDI
PAO FDA UDI
HSD FDA UDI
KWS FDA UDI
GMDN Term
Shoulder glenoid fossa prosthesis, prefabricated FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3670 FDA UDI
888.3650 FDA UDI
888.3660 FDA UDI
888.3690 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
MRI Safety
MR Conditional FDA UDI

Category: Shoulder glenoid fossa prosthesis, prefabricated

Inhance by Depuy (ireland) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Shoulder glenoid fossa prosthesis, prefabricated.

Cleared under the same submission

K212933 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 5363c944-1360-4489-9be3-4efaf5276533 36 fields · synced Jun 8, 2026