SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: SMR Shoulder FDA UDI
Generic Name: Stem-fixed metallic humeral head prosthesis FDA UDI
Device Name: 36mm head adaptor for reverse humeral bodies FDA UDI
Model / Reference: Adaptor FDA UDI
Description: 36mm head adaptor for reverse humeral bodies FDA UDI

Identifiers

Catalog Number: 1352.15.200 FDA UDI
Primary DI / UDI-DI: 08033390002110 FDA UDI
510(k) Number: K131112 FDA UDI
FDA Product Code: HSD FDA UDI
KWS FDA UDI
GMDN Term: Stem-fixed metallic humeral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3660 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

Category: Stem-fixed metallic humeral head prosthesis

SMR Shoulder by Limacorporate — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stem-fixed metallic humeral head prosthesis.

MRS — Howmedica Osteonics Corp. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
GLOBAL ADVANTAGE — DEPUY ORTHOPAEDICS, INC. · Class II
FLEX SHOULDER SYSTEM — TORNIER, INC. · Class II
PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II
Equinoxe — Exactech, Inc. · Class II
TORNIER PERFORM™ HUMERAL SYSTEM — TORNIER, INC. · Class II

Cleared under the same submission

K131112 also covers:

SMR System — Limacorporate

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: Limacorporate

Sources (1)

FDA UDI 8bc96dbe-e50c-42ee-be01-0a9ec678a1ef 36 fields · synced Jun 8, 2026