Atlas FDA

TRINITY ACETABULAR SYSTEM

FDA 510(k) clearance K093472 · decided 2010-11-23

Clearance details

K-number
K093472
Device name
TRINITY ACETABULAR SYSTEM
Applicant
Corin USA
Decision
Substantially Equivalent
Date received
2009-11-06
Decision date
2010-11-23
Days to decision
382 days
Clearance type
Traditional
Product code
MEH
Device class
2
Regulation number
888.3353
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Tampa, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Cormet Hip Resurfacing System (P050016/S012)Corin USA2020-07-17
CORMET HIP RESURFACING SYSTEM (P050016/S011)Corin USA2016-12-21
CORMET HIP RESURFACING SYSTEM (P050016/S010)Corin USA2014-04-03
CORMET HIP RESURFACING SYSTEM (P050016/S009)Corin USA2013-03-22
CORMET HIP RESURFACING SYSTEM (P050016/S008)Corin USA2011-11-10
CORMET HIP RESURFACING SYSTEM (P050016/S007)Corin USA2011-01-13
CORMET HIP RESURFACING SYSTEM (P050016/S006)Corin USA2009-12-31
CORMET HIP RESURFACING SYSTEM (P050016/S005)Corin USA2009-12-03