Atlas FDA

CROSS-OVER ACETABULAR SHELL & LINER

FDA 510(k) clearance K122773 · decided 2012-10-09

Clearance details

K-number
K122773
Device name
CROSS-OVER ACETABULAR SHELL & LINER
Applicant
Stelkast Company
Decision
Substantially Equivalent
Date received
2012-09-10
Decision date
2012-10-09
Days to decision
29 days
Clearance type
Special
Product code
OQG
Device class
2
Regulation number
888.3358
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mcmurray, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stelkast Cross-over Acetabular Shell and Liner Hip System, Part Numbers SC3458-52, SC3474- recall (Z-1066-2013)Stelkast Co2013-04-07

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