Atlas FDA

STELKAST BIPOLAR SYSTEM

FDA 510(k) clearance K972961 · decided 1997-11-04

Clearance details

K-number
K972961
Device name
STELKAST BIPOLAR SYSTEM
Applicant
Stelkast Company
Decision
Substantially Equivalent
Date received
1997-08-11
Decision date
1997-11-04
Days to decision
85 days
Clearance type
Traditional
Product code
JDI
Device class
2
Regulation number
888.3350
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