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Bateman Upf-III Bipolar Endoprosthesis System

by Kirschner Medical Corp. 510(k)

Active United States

510(k) K913632

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK913632 Date13 Nov 1991ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KWY
Device Class
Class II
Regulation
21 CFR Part 888.3390
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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