510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K080259Substantially Equivalent

Jmea Cannulated Bone Screw System

Jmea Corporation, Rockville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080259 is the FDA 510(k) clearance record for JMEA CANNULATED BONE SCREW SYSTEM, a class II device, cleared for Jmea Corporation on under FDA product code HWC (Screw, Fixation, Bone). FDA records list one 510(k) clearance for Jmea Corporation. As of , FDA records show no recalls naming K080259.

Clearance record

Decision date
Received
(202 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Jmea Corporation 1 Research Ct., Suite 450, Rockville MD
510(k) summary
Summary PDF
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