510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K834499Substantially Equivalent

Sheaths for Reinforcing Bone Cement

Mecron Medical Products, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834499 is the FDA 510(k) clearance record for SHEATHS FOR REINFORCING BONE CEMENT, cleared for Mecron Medical Products, Inc. on . FDA records list 14 510(k) clearances for Mecron Medical Products, Inc., from to . As of , FDA records show no recalls naming K834499.

Clearance record

Decision date
Received
(126 days to decision)
Review panel
Unknown
Applicant
Mecron Medical Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No