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-R #MEDIUM FDA UDI
Model / Reference: Compactor FDA UDI
Description: Compactor SMALL-R #MEDIUM FDA UDI

Identifiers

Catalog Number: 9013.75.372 FDA UDI
Primary DI / UDI-DI: 08033390095235 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

Similar devices

Also classified as Orthopaedic ball spike.

OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Limacorporate

Sources (1)

FDA UDI 74e03a7c-34f2-4169-bce5-e035503f968b 35 fields · synced Jun 6, 2026