The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Lcp Dynamic Helical Hip System, Additional Helix Blades.
| Device ID | K042895 |
| 510k Number | K042895 |
| Device Name: | SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-20 |
| Decision Date | 2004-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679282249S0 | K042895 | 000 |
| H679282239S0 | K042895 | 000 |
| H6792822390 | K042895 | 000 |
| H679282238S0 | K042895 | 000 |
| H6792822380 | K042895 | 000 |
| H679282237S0 | K042895 | 000 |
| H6792822370 | K042895 | 000 |
| H679282236S0 | K042895 | 000 |
| H6792822360 | K042895 | 000 |
| H679282235S0 | K042895 | 000 |
| H6792822350 | K042895 | 000 |
| H679282234S0 | K042895 | 000 |
| H6792822400 | K042895 | 000 |
| H679282240S0 | K042895 | 000 |
| H6792822410 | K042895 | 000 |
| H679282248S0 | K042895 | 000 |
| H679282247S0 | K042895 | 000 |
| H679282246S0 | K042895 | 000 |
| H679282245S0 | K042895 | 000 |
| H6792822450 | K042895 | 000 |
| H6792822440 | K042895 | 000 |
| H679282243S0 | K042895 | 000 |
| H6792822430 | K042895 | 000 |
| H679282242S0 | K042895 | 000 |
| H6792822420 | K042895 | 000 |
| H679282241S0 | K042895 | 000 |
| H6792822340 | K042895 | 000 |