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Zavation Rod Connector

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name
ZAVATION ROD CONNECTOR FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,4.75/5.5mm X 3.5/4.0mm FDA UDI
Model / Reference
880-1212-10 FDA UDI
Description
ROD CONNECTOR, PARALLEL SIDE LOADING/CLOSED 10mm offset,4.75/5.5mm X 3.5/4.0mm FDA UDI

Identifiers

Primary DI / UDI-DI
00197157016470 FDA UDI
510(k) Number
K222614 FDA UDI
FDA Product Code
KWQ FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector 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

No

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: Bone-screw internal spinal fixation system connector

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

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

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 dc8e3620-5501-41b0-b5d0-b42ca0099e4a 35 fields · synced May 31, 2026