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
SUBSCRIBE / SIGN IN
K853437Substantially Equivalent

H-H Hunter Tendon Rod

Holter-Hausner Intl., Bridgeport PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853437 is the FDA 510(k) clearance record for H-H HUNTER TENDON ROD, cleared for Holter-Hausner Intl. on . FDA records list 42 510(k) clearances for Holter-Hausner Intl., from to . As of , FDA records show no recalls naming K853437.

Clearance record

Decision date
Received
(62 days to decision)
Review panel
Unknown
Applicant
Holter-Hausner Intl. Third And Mill St.S, Bridgeport PA
Third party review
No