510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K991964Substantially Equivalent

Eis Threaded Screw Fracture Fixation

Groupe Lepine, Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991964 is the FDA 510(k) clearance record for EIS THREADED SCREW FRACTURE FIXATION, a class II device, cleared for Groupe Lepine on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 2 510(k) clearances for Groupe Lepine, from to . As of , FDA records show no recalls naming K991964.

Clearance record

Decision date
Received
(193 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Groupe Lepine 962 S. Tamiami Trl. Suite 203, Sarasota FL
510(k) summary
Statement
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 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 20261