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SMR System

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name
SMR System FDA UDI
Generic Name
Humeral head spacer FDA UDI
Device Name
SMR System - Adaptor 36 mm for Reverse Body FDA UDI
Model / Reference
1352.15.200 FDA UDI
Description
SMR System - Adaptor 36 mm for Reverse Body FDA UDI

Identifiers

Catalog Number
1352.15.200 FDA UDI
Primary DI / UDI-DI
08033390272476 FDA UDI
510(k) Number
K131112 FDA UDI
FDA Product Code
HSD FDA UDI
KWS FDA UDI
GMDN Term
Humeral head spacer 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

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: Humeral head spacer

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

Similar devices

Also classified as Humeral head spacer.

Cleared under the same submission

K131112 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Limacorporate

Sources (1)

  • FDA UDI 107afc46-42a1-4271-b057-5d8bdfa37ce6 36 fields · synced May 30, 2026