The following data is part of a premarket notification filed by Implants International, Ltd with the FDA for Ring-lok Modular Bipolar System.
Device ID | K132539 |
510k Number | K132539 |
Device Name: | RING-LOK MODULAR BIPOLAR SYSTEM |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
Applicant | IMPLANTS INTERNATIONAL, LTD 4170 BOWMANSROOT COURT Hilliard, OH 43026 |
Contact | Trudie Seegar, Phd |
Correspondent | Trudie Seegar, Phd IMPLANTS INTERNATIONAL, LTD 4170 BOWMANSROOT COURT Hilliard, OH 43026 |
Product Code | KWY |
CFR Regulation Number | 888.3390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-08-13 |
Decision Date | 2014-02-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05051693307889 | K132539 | 000 |
05051693307728 | K132539 | 000 |
05051693307711 | K132539 | 000 |
05051693307704 | K132539 | 000 |
05051693307698 | K132539 | 000 |
05051693307681 | K132539 | 000 |
05051693307674 | K132539 | 000 |
05051693307667 | K132539 | 000 |
05051693307650 | K132539 | 000 |
05051693307643 | K132539 | 000 |
05051693307636 | K132539 | 000 |
05051693307629 | K132539 | 000 |
05051693307612 | K132539 | 000 |
05051693307735 | K132539 | 000 |
05051693307742 | K132539 | 000 |
05051693307759 | K132539 | 000 |
05051693307872 | K132539 | 000 |
05051693307865 | K132539 | 000 |
05051693307858 | K132539 | 000 |
05051693307841 | K132539 | 000 |
05051693307834 | K132539 | 000 |
05051693307827 | K132539 | 000 |
05051693307810 | K132539 | 000 |
05051693307803 | K132539 | 000 |
05051693307797 | K132539 | 000 |
05051693307780 | K132539 | 000 |
05051693307773 | K132539 | 000 |
05051693307766 | K132539 | 000 |
05051693307605 | K132539 | 000 |