510(k) K931107
K931107 is an FDA 510(k) premarket notification submitted by Arthronics, Inc. for the device "LOGYK ACETABULAR COMPONENT SYSTEM". The FDA issued a decision of Substantially Equivalent on March 28, 1994. The device falls under product code MBL (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous), a Class II device regulated under 21 CFR 888.3358. Arthronics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1994
- Date Received
- March 3, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type