The following data is part of a premarket notification filed by Implants Intl. Ltd. with the FDA for Rigi-fix Hip Stem System.
| Device ID | K072101 |
| 510k Number | K072101 |
| Device Name: | RIGI-FIX HIP STEM SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | IMPLANTS INTL. LTD. 71 JAY AVE. TEESSIDE INDUSTRIAL EST. Thornaby-on-tees, GB T517 9lz |
| Contact | Mohan Emmanuel |
| Correspondent | Mohan Emmanuel IMPLANTS INTL. LTD. 71 JAY AVE. TEESSIDE INDUSTRIAL EST. Thornaby-on-tees, GB T517 9lz |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-31 |
| Decision Date | 2007-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051693303881 | K072101 | 000 |
| 05051693303607 | K072101 | 000 |
| 05051693303591 | K072101 | 000 |
| 05051693303553 | K072101 | 000 |
| 05051693303546 | K072101 | 000 |
| 05051693303539 | K072101 | 000 |
| 05051693303515 | K072101 | 000 |
| 05051693301306 | K072101 | 000 |
| 05051693301290 | K072101 | 000 |
| 05051693301283 | K072101 | 000 |
| 05051693301276 | K072101 | 000 |
| 05051693301269 | K072101 | 000 |
| 05051693301252 | K072101 | 000 |
| 05051693301245 | K072101 | 000 |
| 05051693301238 | K072101 | 000 |
| 05051693301221 | K072101 | 000 |
| 05051693303614 | K072101 | 000 |
| 05051693303621 | K072101 | 000 |
| 05051693303638 | K072101 | 000 |
| 05051693303874 | K072101 | 000 |
| 05051693303867 | K072101 | 000 |
| 05051693303850 | K072101 | 000 |
| 05051693303812 | K072101 | 000 |
| 05051693303805 | K072101 | 000 |
| 05051693303799 | K072101 | 000 |
| 05051693303782 | K072101 | 000 |
| 05051693303775 | K072101 | 000 |
| 05051693303768 | K072101 | 000 |
| 05051693303751 | K072101 | 000 |
| 05051693303744 | K072101 | 000 |
| 05051693303737 | K072101 | 000 |
| 05051693303720 | K072101 | 000 |
| 05051693303713 | K072101 | 000 |
| 05051693303706 | K072101 | 000 |
| 05051693301214 | K072101 | 000 |