510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011076Substantially Equivalent

Lorenz Sternal Closure System with Modular Screw

Biomet Microfixation, Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011076 is the FDA 510(k) clearance record for LORENZ STERNAL CLOSURE SYSTEM WITH MODULAR SCREW, a class II device, cleared for Walter Lorenz Surgical, Inc. on under FDA product code HRS (Plate, Fixation, Bone). FDA records list 86 510(k) clearances for BIOMET MICROFIXATION, from to . As of , FDA records show no recalls naming K011076.

Clearance record

Decision date
Received
(98 days to decision)
Product code
HRS Plate, Fixation, Bone
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Walter Lorenz Surgical, Inc. 1520 Tradeport Dr., Jacksonville FL
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