Kmedic

FDA UDI

Class I (US FDA UDI)

by Teleflex Incorporated

Identity

Trade Name: KMEDIC FDA UDI
Generic Name: Orthopaedic ball spike FDA UDI
Device Name: BALL SPIKE PELVIC STRAIGHT 300 MILLIMETER FDA UDI
Model / Reference: IPN014317 FDA UDI
Description: BALL SPIKE PELVIC STRAIGHT 300 MILLIMETER FDA UDI

Identifiers

Catalog Number: KM47906 FDA UDI
Primary DI / UDI-DI: 24026704276152 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic ball spike FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 30 Centimeter FDA UDI

Category: Orthopaedic ball spike

Kmedic by Teleflex Incorporated — Class I — 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
SMR Shoulder — Limacorporate · Class II
SMR Shoulder — Limacorporate · Class II
Straight Ball Spike — I.T.S. GmbH · Class II
OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II

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 I	Pending data

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Manufacturer

Manufacturer: Teleflex Incorporated

Sources (1)

FDA UDI 7fd4fc57-19e9-4834-baa6-db8b6b7319b9 36 fields · synced May 30, 2026