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Zavation Pedicle Screw Head Assembly Tool

FDA UDI

Class I (US FDA UDI)

by Zavation

Identity

Trade Name
Zavation Pedicle Screw Head Assembly Tool FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Pedicle Screw Head Assembly Tool/4.5,8.5, & 9.5 FDA UDI
Model / Reference
ZAV-1353-2 FDA UDI
Description
Pedicle Screw Head Assembly Tool/4.5,8.5, & 9.5 FDA UDI

Identifiers

Primary DI / UDI-DI
00197157019648 FDA UDI
510(k) Number
K112484 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

Zavation Pedicle Screw Head Assembly Tool by Zavation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Cleared under the same submission

K112484 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zavation

Sources (1)

  • FDA UDI 160bb134-0275-410c-a629-e0f71b6bd083 35 fields · synced May 29, 2026