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 |