510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830185Substantially Equivalent

Univ. Knee, Cutting Instrumentation

Intermedics Orthopedics, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830185 is the FDA 510(k) clearance record for UNIV. KNEE, CUTTING INSTRUMENTATION, cleared for Intermedics Orthopedics on . FDA records list 108 510(k) clearances for Intermedics Orthopedics, from to . As of , FDA records show no recalls naming K830185.

Clearance record

Decision date
Received
(49 days to decision)
Review panel
Unknown
Applicant
Intermedics Orthopedics 803 N. Front St. Suite 3, Mchenry IL
Third party review
No