Zavation Rod Bender 989-1067-R

by Zavation GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00197157071837 UDI-DI	Date16 Sep 2025Listed	StatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name: Zavation Rod Bender
Generic Name: Manual orthopaedic bender, reusable
Model / Reference: 989-1067-R
Description: CORONAL BENDER RIGHT - 6.0 ROD

Primary DI / UDI-DI: 00197157071837
510(k) Number: K243908
FDA Product Code: NKB
GMDN Term: Manual orthopaedic bender, reusable

Device Class: Class II
Regulation Number: 888.3070
GUDID distribution status: In Commercial Distribution

Sterilization Method: Moist Heat or Steam Sterilization

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Properties

Prescription Use
Lot / Batch Number

Other properties (12)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No