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Zavation

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name
Zavation FDA UDI
Generic Name
Bone tap, reusable FDA UDI
Device Name
5.5mm Cannulated Tap FDA UDI
Model / Reference
389-1075-55 FDA UDI
Description
5.5mm Cannulated Tap FDA UDI

Identifiers

Primary DI / UDI-DI
00197157005856 FDA UDI
510(k) Number
K222614 FDA UDI
FDA Product Code
KWQ FDA UDI
NKB FDA UDI
GMDN Term
Bone tap, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3060 FDA UDI
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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 tap, reusable

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

Similar devices

Also classified as Bone tap, reusable.

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 bd166a17-1e38-47d5-bb89-41288faca634 35 fields · synced May 30, 2026