510(k) K850840

HOWMEDICA THREADED ACETABULAR COMPONENT by Pfizer, Inc. — Product Code KWA

K850840 is an FDA 510(k) premarket notification submitted by Pfizer, Inc. for the device "HOWMEDICA THREADED ACETABULAR COMPONENT". The FDA issued a decision of Substantially Equivalent on July 15, 1985. 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. Pfizer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1985
Date Received
March 1, 1985
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