Zavation CUSTOM CERVICAL DRILL

FDA UDI

Class I (US FDA UDI)

by Zavation

Identity

Trade Name: Zavation CUSTOM CERVICAL DRILL FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: CUSTOM CERVICAL DRILL FDA UDI
Model / Reference: ZAV-1372 FDA UDI
Description: CUSTOM CERVICAL DRILL FDA UDI

Identifiers

Primary DI / UDI-DI: 00197157049935 FDA UDI
510(k) Number: K112533 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable 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

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

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: Manual surgical rotary handpiece, reusable

Zavation CUSTOM CERVICAL DRILL by Zavation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual surgical rotary handpiece, reusable.

RENOIR Posterior Cervico-Thoracic Fixation System — CTL Medical Corporation · Class I
MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO — W.H. Holden, Inc. · Class I
Invivo — Philips DS North America LLC · Class II
GII — Medos International Sàrl · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
HNM Medical — HNM STAINLESS, LLC. · Class I
HALLMARK — Orthofix US LLC · Class I
CHESAPEAKE Stabilization System — K2M, INC. · Class I

Cleared under the same submission

K112533 also covers:

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: Zavation

Sources (1)

FDA UDI a210a641-6168-4d37-a699-bf02bfd8bc97 35 fields · synced Jun 1, 2026