510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K982545Substantially Equivalent

Bmp Cable System

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

K982545 is the FDA 510(k) clearance record for BMP CABLE SYSTEM, a class II device, cleared for Biomet, Inc. on under FDA product code JDQ (Cerclage, Fixation). FDA records list 872 510(k) clearances for ZIMMER GMBH, from to . As of , FDA records show one recall naming K982545.

Clearance record

Decision date
Received
(90 days to decision)
Product code
JDQ Cerclage, Fixation
Regulation
21 CFR 888.3010
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet, Inc. Airport Industrial Park, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code JDQ

Trailing 12 months
1 clearance under product code JDQ in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260