Zavation

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name: Zavation FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Polyaxial Screw, Reduction, 8.5x90 FDA UDI
Model / Reference: 12-8590 FDA UDI
Description: Polyaxial Screw, Reduction, 8.5x90 FDA UDI

Identifiers

Primary DI / UDI-DI: 00842166102132 FDA UDI
FDA Product Code: MNI FDA UDI
MNH FDA UDI
KWP FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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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

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Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Zavation is a polyaxial screw, reduction orthosis for spinal pedicle fixation. It provides stable and accurate alignment of the spine, allowing patients to regain mobility and independence after surgical procedures. Our device is designed with safety in mind, adhering to strict sterilization protocols and containing no MRI safety information. With its robust design and easy-to-use interface, Zavation is an ideal solution for medical professionals seeking a reliable orthosis for spinal fixation.

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II
ARIX System Bone Screw — Jeil Medical Corporation · 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 II	Pending data

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Manufacturer

Manufacturer: Zavation

Sources (1)

FDA UDI d370db22-427d-4228-a565-8a2b44fa35b9 34 fields · synced Jul 30, 2026