Zavation Inserter Graft Pusher

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name: Zavation Inserter Graft Pusher FDA UDI
Generic Name: Orthopaedic graft inserter, reusable FDA UDI
Device Name: Custom Inserter Graft Pusher FDA UDI
Model / Reference: ZAV-1356 FDA UDI
Description: Custom Inserter Graft Pusher FDA UDI

Identifiers

Primary DI / UDI-DI: 00197157019600 FDA UDI
510(k) Number: K191339 FDA UDI
FDA Product Code: ODP FDA UDI
MAX FDA UDI
GMDN Term: Orthopaedic graft inserter, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

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: Orthopaedic graft inserter, reusable

Zavation Inserter Graft Pusher by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic graft inserter, reusable.

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INTRAFIX — DePuy Mitek, Inc. · Class I
Kalitec Disc Prep — Kalitec Direct LLC · Class I
PRESTIGE LP™ — MEDTRONIC SOFAMOR DANEK, INC. · Class III

Cleared under the same submission

K191339 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 II	Pending data

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Manufacturer

Manufacturer: Zavation

Sources (1)

FDA UDI 759c7354-e793-4727-9855-e0c0e950852b 35 fields · synced Jun 8, 2026