510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K983967Substantially Equivalent

Pediatric Cannulated Osteotomy Plates

Zimmer GmbH, Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983967 is the FDA 510(k) clearance record for PEDIATRIC CANNULATED OSTEOTOMY PLATES, a class II device, cleared for Biomet, Inc. on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show no recalls naming K983967.

Clearance record

Decision date
Received
(40 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code HRS

Trailing 12 months
57 clearances under product code HRS in the twelve months to November 2026, March 2026 the highest month at 13.
Show the numbers
Monthly 510(k) clearances under FDA product code HRS, trailing twelve months
MonthClearances
December 20255
January 20264
February 20265
March 202613
April 20266
May 20262
June 20265
July 20265
August 20263
September 20265
October 20264
November 20260