The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 3.5 Mm 90 Cannulated Limited Contact Angeled Blade Plates (3.5mm 90 Cannulated Lc-abp).
| Device ID | K992837 |
| 510k Number | K992837 |
| Device Name: | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | SYNTHES (USA) 1600 RUSSELL RD. Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1600 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794320890 | K992837 | 000 |
| H6792320590 | K992837 | 000 |
| H6792320660 | K992837 | 000 |
| H6792320670 | K992837 | 000 |
| H6792320680 | K992837 | 000 |
| H6792320690 | K992837 | 000 |
| H6792320860 | K992837 | 000 |
| H6792320870 | K992837 | 000 |
| H6792320880 | K992837 | 000 |
| H6792320580 | K992837 | 000 |
| H6792320570 | K992837 | 000 |
| H6792320070 | K992837 | 000 |
| H6792320080 | K992837 | 000 |
| H6792320090 | K992837 | 000 |
| H6792320460 | K992837 | 000 |
| H6792320470 | K992837 | 000 |
| H6792320480 | K992837 | 000 |
| H6792320490 | K992837 | 000 |
| H6792320560 | K992837 | 000 |
| H6792320890 | K992837 | 000 |
| H6794320060 | K992837 | 000 |
| H6794320590 | K992837 | 000 |
| H6794320660 | K992837 | 000 |
| H6794320670 | K992837 | 000 |
| H6794320680 | K992837 | 000 |
| H6794320690 | K992837 | 000 |
| H6794320860 | K992837 | 000 |
| H6794320870 | K992837 | 000 |
| H6794320880 | K992837 | 000 |
| H6794320580 | K992837 | 000 |
| H6794320570 | K992837 | 000 |
| H6794320070 | K992837 | 000 |
| H6794320080 | K992837 | 000 |
| H6794320090 | K992837 | 000 |
| H6794320460 | K992837 | 000 |
| H6794320470 | K992837 | 000 |
| H6794320480 | K992837 | 000 |
| H6794320490 | K992837 | 000 |
| H6794320560 | K992837 | 000 |
| H6792320060 | K992837 | 000 |