SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: SMR Shoulder FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: Bone Graft Instrument Set - Graft Cutter FDA UDI
Model / Reference: Bone Graft Instrument Set FDA UDI
Description: Bone Graft Instrument Set - Graft Cutter FDA UDI

Identifiers

Catalog Number: 9013.75.443 FDA UDI
Primary DI / UDI-DI: 08033390105866 FDA UDI
510(k) Number: K161120 FDA UDI
FDA Product Code: KWS FDA UDI
KWT FDA UDI
PHX FDA UDI
GMDN Term: Bone cutter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3660 FDA UDI
888.3650 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone cutter

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

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IdentiTi — ALPHATEC SPINE, INC. · Class I
Park Dental Research Corp. — Park Dental Research Corp · Class II

Cleared under the same submission

K161120 also covers:

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 f5e763b6-1464-4019-8e3f-baecff60a88b 35 fields · synced May 31, 2026