SMR Shoulder

FDA UDI

Class II (US FDA UDI)

by Limacorporate

Identity

Trade Name: SMR Shoulder FDA UDI
Generic Name: Orthopaedic ball spike FDA UDI
Device Name: Compactor SMALL/STD/LARGE #X-LONG FDA UDI
Model / Reference: Compactor FDA UDI
Description: Compactor SMALL/STD/LARGE #X-LONG FDA UDI

Identifiers

Catalog Number: 9013.75.384 FDA UDI
Primary DI / UDI-DI: 08033390095297 FDA UDI
FDA Product Code: KWS FDA UDI
KWT FDA UDI
GMDN Term: Orthopaedic ball spike 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: Orthopaedic ball spike

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

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Also classified as Orthopaedic ball spike.

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gSource — GSOURCE, LLC. · Class I
gSource — GSOURCE, LLC. · Class I
Bone Spike, Straight — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
Straight Ball Spike — I.T.S. GmbH · Class II
OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
KMEDIC — TELEFLEX INCORPORATED · Class I
8MM BALL SPIKE PUSHER WITH HANDLE — Zimmer, Inc. · Class I

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 6245a5c6-31ce-47bb-9efe-d242376a1046 35 fields · synced May 30, 2026