Intervertebral Disc Preparation Instruments

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Intervertebral Disc Preparation Instruments FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: LIF, BROACH, STRAIGHT, 16MM X 04MM FDA UDI
Model / Reference: 256-15-000-1604 FDA UDI
Description: LIF, BROACH, STRAIGHT, 16MM X 04MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00190376380582 FDA UDI
FDA Product Code: HTQ FDA UDI
GMDN Term: Bone cutter 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Height — 4 Millimeter FDA UDI
Width — 16 Millimeter FDA UDI

Category: Bone cutter

Intervertebral Disc Preparation Instruments by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Alphatec Spine, Inc.

Sources (1)

FDA UDI aa04d5e4-6fc0-4b05-99a6-22ae4e82ec22 35 fields · synced Jun 8, 2026