Zavation

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name: Zavation FDA UDI
Generic Name: Interspinous spinal fixation implant FDA UDI
Device Name: Implant Holder FDA UDI
Model / Reference: 200-1008 FDA UDI
Description: Implant Holder FDA UDI

Identifiers

Primary DI / UDI-DI: 00842166121027 FDA UDI
510(k) Number: K161016 FDA UDI
FDA Product Code: PEK FDA UDI
GMDN Term: Interspinous spinal fixation implant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Interspinous spinal fixation implant

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

Similar devices

Also classified as Interspinous spinal fixation implant.

Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II

Cleared under the same submission

K161016 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 de5ee2c9-6b7a-405c-a4ec-5c9d9d87fac1 35 fields · synced May 30, 2026