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Zavation Deformity Polyaxial Head – Biased Angle

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name
Zavation Deformity Polyaxial Head – Biased Angle FDA UDI
Generic Name
Spinal bone screw head/rod adaptor FDA UDI
Device Name
Deformity Polyaxial Head – Biased Angle FDA UDI
Model / Reference
1010-2005 FDA UDI
Description
Deformity Polyaxial Head – Biased Angle FDA UDI

Identifiers

Primary DI / UDI-DI
00197157026929 FDA UDI
510(k) Number
K222614 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Spinal bone screw head/rod adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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: Spinal bone screw head/rod adaptor

Zavation Deformity Polyaxial Head – Biased Angle by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw head/rod adaptor.

Cleared under the same submission

K222614 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 106c7704-f3e7-419a-a32d-6da0e8df2aa6 34 fields · synced Jun 8, 2026