510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
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K861826Substantially Equivalent

Kirschner Proximal Femur Total Hip System

Kirschner Medical Corp., Timonium MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861826 is the FDA 510(k) clearance record for KIRSCHNER PROXIMAL FEMUR TOTAL HIP SYSTEM, cleared for Kirschner Medical Corp. on . FDA records list 76 510(k) clearances for Kirschner Medical Corp., from to . As of , FDA records show no recalls naming K861826.

Clearance record

Decision date
Received
(87 days to decision)
Review panel
Unknown
Applicant
Kirschner Medical Corp. 9690 Deereco Rd.D, Timonium MD
Third party review
No