The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Stainless Steel Modular Hand System.
| Device ID | K030310 |
| 510k Number | K030310 |
| Device Name: | SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM |
| 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 | 2003-01-30 |
| Decision Date | 2003-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792005260 | K030310 | 000 |
| H6792006900 | K030310 | 000 |
| H6792006910 | K030310 | 000 |
| H6792006920 | K030310 | 000 |
| H6792006930 | K030310 | 000 |
| H6792006940 | K030310 | 000 |
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| H6792018090 | K030310 | 000 |
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| H6792005310 | K030310 | 000 |
| H6792005320 | K030310 | 000 |
| H6792005330 | K030310 | 000 |
| H6792005340 | K030310 | 000 |
| H6792006860 | K030310 | 000 |
| H6792006870 | K030310 | 000 |
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| H6792213120 | K030310 | 000 |
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| H6792213340 | K030310 | 000 |
| H6792213350 | K030310 | 000 |
| H6792430910 | K030310 | 000 |
| H6792460310 | K030310 | 000 |
| H6792461910 | K030310 | 000 |
| H6792462330 | K030310 | 000 |
| H6792462340 | K030310 | 000 |
| H67931292960 | K030310 | 000 |