510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013534Substantially Equivalent

Self-Countersinking Bone Screw

Biomet Orthopedics, Inc., Warsaw IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013534 is the FDA 510(k) clearance record for SELF-COUNTERSINKING BONE SCREW, a class II device, cleared for Biomet Orthopedics, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 40 510(k) clearances for Biomet Orthopedics, Inc., from to . As of , FDA records show no recalls naming K013534.

Clearance record

Decision date
Received
(55 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Biomet Orthopedics, Inc. P.O. Box 587, Warsaw IN
510(k) summary
Summary
Third party review
No

Clearances, product code HWC

Trailing 12 months
21 clearances under product code HWC in the twelve months to October 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20260