The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Dentoalveolar Bone Fixation System.
| Device ID | K102656 |
| 510k Number | K102656 |
| Device Name: | SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2010-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804210800 | K102656 | 000 |
| 20887587042333 | K102656 | 000 |
| 20887587042364 | K102656 | 000 |
| 20887587042425 | K102656 | 000 |
| 20887587042456 | K102656 | 000 |
| 20887587042487 | K102656 | 000 |
| 20887587042517 | K102656 | 000 |
| 20887587042548 | K102656 | 000 |
| 20887587042579 | K102656 | 000 |
| 20887587042876 | K102656 | 000 |
| 20887587042890 | K102656 | 000 |
| 20887587042920 | K102656 | 000 |
| 20887587042944 | K102656 | 000 |
| 20887587042999 | K102656 | 000 |
| 20887587043040 | K102656 | 000 |
| 20887587043071 | K102656 | 000 |
| 20887587043101 | K102656 | 000 |
| 20887587042302 | K102656 | 000 |
| 20887587042272 | K102656 | 000 |
| H9804210990 | K102656 | 000 |
| H9804211020 | K102656 | 000 |
| H9804211030 | K102656 | 000 |
| H9804211040 | K102656 | 000 |
| 20887587041886 | K102656 | 000 |
| 20887587041916 | K102656 | 000 |
| 20887587041930 | K102656 | 000 |
| 20887587041985 | K102656 | 000 |
| H9804000400 | K102656 | 000 |
| H9804000420 | K102656 | 000 |
| 20887587042074 | K102656 | 000 |
| 20887587042104 | K102656 | 000 |
| 20887587042135 | K102656 | 000 |
| 20887587042159 | K102656 | 000 |
| 20887587042180 | K102656 | 000 |
| 20887587042210 | K102656 | 000 |
| 20887587043132 | K102656 | 000 |
| 20887587043163 | K102656 | 000 |
| 20887587043187 | K102656 | 000 |
| H9804010460 | K102656 | 000 |
| H9804010470 | K102656 | 000 |
| H9804010480 | K102656 | 000 |
| H9804010490 | K102656 | 000 |
| H9804010500 | K102656 | 000 |
| H9804010610 | K102656 | 000 |
| H9804010620 | K102656 | 000 |
| H9804010630 | K102656 | 000 |
| H9804010640 | K102656 | 000 |
| H9804010650 | K102656 | 000 |
| H9804017910 | K102656 | 000 |
| H9804017920 | K102656 | 000 |
| H9804017940 | K102656 | 000 |
| H9804017950 | K102656 | 000 |
| H9804017960 | K102656 | 000 |
| H9804017970 | K102656 | 000 |
| H9804010450 | K102656 | 000 |
| H9804010440 | K102656 | 000 |
| 20887587043217 | K102656 | 000 |
| 20887587043248 | K102656 | 000 |
| 20887587043279 | K102656 | 000 |
| 20887587043545 | K102656 | 000 |
| 20887587043576 | K102656 | 000 |
| 20887587043606 | K102656 | 000 |
| 20887587043637 | K102656 | 000 |
| 20887587043682 | K102656 | 000 |
| 20887587043736 | K102656 | 000 |
| 20887587043767 | K102656 | 000 |
| 20887587043798 | K102656 | 000 |
| 20887587043828 | K102656 | 000 |
| 20887587043859 | K102656 | 000 |
| H9804010410 | K102656 | 000 |
| H9804010420 | K102656 | 000 |
| H9804010430 | K102656 | 000 |
| H9804017980 | K102656 | 000 |