The following data is part of a premarket notification filed by Sulzer Medica with the FDA for Modified To Modular Fr Severe Bone Loss Trauma.
| Device ID | K002324 |
| 510k Number | K002324 |
| Device Name: | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | SULZER MEDICA 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison SULZER MEDICA 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JDI |
| Subsequent Product Code | KRO |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-31 |
| Decision Date | 2000-08-24 |