510(k) K962541
K962541 is an FDA 510(k) premarket notification submitted by Smith & Nephew Richards, Inc. for the device "REFLECTION ACETABULAR REINFORCEMENT RINGS". The FDA issued a decision of Substantially Equivalent on September 17, 1996. The device falls under product code JDJ (Mesh, Surgical, Acetabular, Hip, Prosthesis), a Class II device regulated under 21 CFR 878.3300. Smith & Nephew Richards, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 1996
- Date Received
- June 28, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Acetabular, Hip, Prosthesis
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- OR
- Submission Type