510(k) K922868

THOMPSON TYPE HIP PROTHESIS by Osteo Technology, Inc. — Product Code KWA

K922868 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "THOMPSON TYPE HIP PROTHESIS". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3330. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
June 4, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device Class
Class III
Regulation Number
888.3330
Review Panel
OR
Submission Type