The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synths One-third Tubular Dcl Plate.
| Device ID | K011335 |
| 510k Number | K011335 |
| Device Name: | SYNTHS ONE-THIRD TUBULAR DCL PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792414210 | K011335 | 000 |
| H6794413410 | K011335 | 000 |
| H6794413510 | K011335 | 000 |
| H6794413610 | K011335 | 000 |
| H6794413710 | K011335 | 000 |
| H6794413810 | K011335 | 000 |
| H6794413910 | K011335 | 000 |
| H6794414010 | K011335 | 000 |
| H6794414210 | K011335 | 000 |
| H6792413310 | K011335 | 000 |
| H6792413410 | K011335 | 000 |
| H6792413510 | K011335 | 000 |
| H6792413610 | K011335 | 000 |
| H6792413710 | K011335 | 000 |
| H6792413810 | K011335 | 000 |
| H6792413910 | K011335 | 000 |
| H6792414010 | K011335 | 000 |
| H6794413310 | K011335 | 000 |