510(k) K042841
K042841 is an FDA 510(k) premarket notification submitted by Biomet, Inc. for the device "M2A/C2A ACETABULAR SYSTEM". The FDA issued a decision of Substantially Equivalent on December 21, 2004. The device falls under product code JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)), a Class III device regulated under 21 CFR 888.3320. Biomet, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2004
- Date Received
- October 14, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Device Class
- Class III
- Regulation Number
- 888.3320
- Review Panel
- OR
- Submission Type