Calibrate

FDA UDI

Class I (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Calibrate FDA UDI
Generic Name: Surgical instrument handle, torque-limiting FDA UDI
Device Name: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 13 IN-LBS, GREEN FDA UDI
Model / Reference: 86002-1500-013-004 FDA UDI
Description: 3/16" SQ TORQUE LIMITING AXIAL HANDLE, 13 IN-LBS, GREEN FDA UDI

Identifiers

Primary DI / UDI-DI: 00190376521664 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical instrument handle, torque-limiting 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

Category: Surgical instrument handle, torque-limiting

Calibrate by Alphatec Spine, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Tecomet — Tecomet,Inc · Class I
ReLine — Nuvasive, Inc. · Class I
InCore MPJ — Medartis Inc. · Class I
KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm — Icotec · 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: Alphatec Spine, Inc.

Sources (1)

FDA UDI 52143a54-9b03-4ebe-85b3-40d76271c3c0 34 fields · synced Jun 8, 2026