510(k) K936044
K936044 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ENHANCED MODULAR AUSTIN MOORE HIP". The FDA issued a decision of Substantially Equivalent on April 26, 1994. The device falls under product code KMC (Prosthesis, Hip, Semi-Constrained, Composite/Metal), a Class II device regulated under 21 CFR 888.3340. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 26, 1994
- Date Received
- December 20, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Composite/Metal
- Device Class
- Class II
- Regulation Number
- 888.3340
- Review Panel
- OR
- Submission Type