510(k) K132539
K132539 is an FDA 510(k) premarket notification submitted by Implants International, Ltd. for the device "RING-LOK MODULAR BIPOLAR SYSTEM". The FDA issued a decision of Substantially Equivalent on February 7, 2014. The device falls under product code KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented), a Class II device regulated under 21 CFR 888.3390. Implants International, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 2014
- Date Received
- August 13, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3390
- Review Panel
- OR
- Submission Type