510(k) K850840
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