The following data is part of a premarket notification filed by Implants International, Ltd with the FDA for Cermet Iii Acetabular Cup System.
| Device ID | K071583 |
| 510k Number | K071583 |
| Device Name: | CERMET III ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | IMPLANTS INTERNATIONAL, LTD 71 JAY AVE.TEESIDE INDSTRL.EST THORNABY-ON TEES United Kingdom, GB T517-9lz |
| Contact | Mohan Emmanuel |
| Correspondent | Mohan Emmanuel IMPLANTS INTERNATIONAL, LTD 71 JAY AVE.TEESIDE INDSTRL.EST THORNABY-ON TEES United Kingdom, GB T517-9lz |
| Product Code | MEH |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-08 |
| Decision Date | 2007-07-25 |
| Summary: | summary |