Atlas FDA

EPOCA CODR STEM AND HEAD

FDA 510(k) clearance K014049 · decided 2002-01-09

Clearance details

K-number
K014049
Device name
EPOCA CODR STEM AND HEAD
Applicant
Stelkast Company
Decision
Substantially Equivalent
Date received
2001-12-10
Decision date
2002-01-09
Days to decision
30 days
Clearance type
Special
Product code
KWT
Device class
2
Regulation number
888.3650
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Pittsburgh, PA, 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
STELKAST SURPASS ACETABULAR SYSTEM (P040051/S002)Stelkast Company2011-04-22
STELKAST SURPASS ACETABULAR SYSTEM (P040051/S001)Stelkast Company2009-05-08
STELKAST SURPASS ACETABULAR SYSTEM (P040051)Stelkast Company2006-05-12