510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K963739Substantially Equivalent for Some Indications

Leibinger - Luhr Small Orthopedic Bone Screws

Howmedica Leibinger, Inc., Dallas TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K963739 is the FDA 510(k) clearance record for LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWS, a class II device, cleared for Howmedica Leibinger, Inc. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 11 510(k) clearances for Howmedica Leibinger, Inc., from to . As of , FDA records show no recalls naming K963739.

Clearance record

Decision date
Received
(127 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Howmedica Leibinger, Inc. 14540 Beltwood Pkwy. E., Dallas TX
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