KMC Vertebral Osteotome

FDA UDI

Class I (US FDA UDI)

by Shanghai Kinetic Medical Co., Ltd.

Identity

Trade Name: KMC Vertebral Osteotome FDA UDI
Generic Name: Bone access channel kit FDA UDI
Device Name: KMC Vertebral Osteotome FDA UDI
Model / Reference: VO1102 FDA UDI
Description: KMC Vertebral Osteotome FDA UDI

Identifiers

Catalog Number: VO1102 FDA UDI
Primary DI / UDI-DI: 06938695502117 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Bone access channel kit 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 60 Centimeter FDA UDI
Pressure — 440 Pound per Square Inch FDA UDI

Category: Bone access channel kit

KMC Vertebral Osteotome by Shanghai Kinetic Medical Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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0.035" x 5" K-Wire Standard — Trilliant Surgical LLC · Class II
OSTEOCOOL KIT BONE ACCESS 10G 095 — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Kyphon V™ Osteo Introducer® 11Ga Bevel KIT — MEDTRONIC SOFAMOR DANEK, 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 I	Pending data

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Manufacturer

Manufacturer: Shanghai Kinetic Medical Co., Ltd.

Sources (1)

FDA UDI de89865a-770e-4fda-b827-225e8ee6583f 37 fields · synced May 30, 2026