The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Low Profile Reconstruction Plates.
| Device ID | K042377 |
| 510k Number | K042377 |
| Device Name: | SYNTHES LOW PROFILE RECONSTRUCTION PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. 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 | 2004-09-01 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792459200 | K042377 | 000 |
| H679021001050 | K042377 | 000 |
| H679021001060 | K042377 | 000 |
| H679021001070 | K042377 | 000 |
| H679021001080 | K042377 | 000 |
| H679021001090 | K042377 | 000 |
| H679021001100 | K042377 | 000 |
| H679021001110 | K042377 | 000 |
| H679021001120 | K042377 | 000 |
| H679021001130 | K042377 | 000 |
| H679021001140 | K042377 | 000 |
| H679021001150 | K042377 | 000 |
| H679021001040 | K042377 | 000 |
| H679021001030 | K042377 | 000 |
| H6792459220 | K042377 | 000 |
| H6792459240 | K042377 | 000 |
| H6792459260 | K042377 | 000 |
| H6792459300 | K042377 | 000 |
| H6792459320 | K042377 | 000 |
| H6792459340 | K042377 | 000 |
| H6792459360 | K042377 | 000 |
| H679021000040 | K042377 | 000 |
| H679021000060 | K042377 | 000 |
| H679021000140 | K042377 | 000 |
| H679021000160 | K042377 | 000 |
| H679021001160 | K042377 | 000 |
| H679021001180 | K042377 | 000 |
| H679021002150 | K042377 | 000 |
| H679021002160 | K042377 | 000 |
| H679021002180 | K042377 | 000 |
| H679021002200 | K042377 | 000 |
| H679021003600 | K042377 | 000 |
| H679021003610 | K042377 | 000 |
| H679021003620 | K042377 | 000 |
| H679021003630 | K042377 | 000 |
| H679021003640 | K042377 | 000 |
| H679021003650 | K042377 | 000 |
| H679021003660 | K042377 | 000 |
| H679021002140 | K042377 | 000 |
| H679021002130 | K042377 | 000 |
| H679021001200 | K042377 | 000 |
| H679021002030 | K042377 | 000 |
| H679021002040 | K042377 | 000 |
| H679021002050 | K042377 | 000 |
| H679021002060 | K042377 | 000 |
| H679021002070 | K042377 | 000 |
| H679021002080 | K042377 | 000 |
| H679021002090 | K042377 | 000 |
| H679021002100 | K042377 | 000 |
| H679021002110 | K042377 | 000 |
| H679021002120 | K042377 | 000 |
| H679021003670 | K042377 | 000 |