The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.5 Mm Titanium Lcp Proximal Tibia Plating System.
| Device ID | K023802 |
| 510k Number | K023802 |
| Device Name: | SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-14 |
| Decision Date | 2003-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794225780 | K023802 | 000 |
| H679440042S0 | K023802 | 000 |
| H6794400430 | K023802 | 000 |
| H679440043S0 | K023802 | 000 |
| H6794400440 | K023802 | 000 |
| H679440044S0 | K023802 | 000 |
| H6794400450 | K023802 | 000 |
| H679440045S0 | K023802 | 000 |
| H6794400460 | K023802 | 000 |
| H679440046S0 | K023802 | 000 |
| H6794400470 | K023802 | 000 |
| H679440047S0 | K023802 | 000 |
| H6794400420 | K023802 | 000 |
| H679440041S0 | K023802 | 000 |
| H6794400360 | K023802 | 000 |
| H679440036S0 | K023802 | 000 |
| H6794400370 | K023802 | 000 |
| H679440037S0 | K023802 | 000 |
| H6794400380 | K023802 | 000 |
| H679440038S0 | K023802 | 000 |
| H6794400390 | K023802 | 000 |
| H679440039S0 | K023802 | 000 |
| H6794400400 | K023802 | 000 |
| H679440040S0 | K023802 | 000 |
| H6794400410 | K023802 | 000 |
| H679042050250 | K023802 | 000 |
| H679042050300 | K023802 | 000 |
| H679042052400 | K023802 | 000 |
| H679042052450 | K023802 | 000 |
| H679042052500 | K023802 | 000 |
| H679042052550 | K023802 | 000 |
| H679042052600 | K023802 | 000 |
| H679042052650 | K023802 | 000 |
| H679042052700 | K023802 | 000 |
| H679042052750 | K023802 | 000 |
| H679042052800 | K023802 | 000 |
| H679042052850 | K023802 | 000 |
| H679042052900 | K023802 | 000 |
| H679042050950 | K023802 | 000 |
| H679042050900 | K023802 | 000 |
| H679042050350 | K023802 | 000 |
| H679042050400 | K023802 | 000 |
| H679042050450 | K023802 | 000 |
| H679042050500 | K023802 | 000 |
| H679042050550 | K023802 | 000 |
| H679042050600 | K023802 | 000 |
| H679042050650 | K023802 | 000 |
| H679042050700 | K023802 | 000 |
| H679042050750 | K023802 | 000 |
| H679042050800 | K023802 | 000 |
| H679042050850 | K023802 | 000 |
| H679042052950 | K023802 | 000 |