The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Spiral Blade For Humeral Nail (sbhn).
| Device ID | K992348 |
| 510k Number | K992348 |
| Device Name: | SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) |
| Classification | Nail, Fixation, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-14 |
| Decision Date | 1999-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794626600 | K992348 | 000 |
| H6794626460 | K992348 | 000 |
| H679462644S0 | K992348 | 000 |
| H6794626440 | K992348 | 000 |
| H679462642S0 | K992348 | 000 |
| H6794626420 | K992348 | 000 |
| H679462640S0 | K992348 | 000 |
| H6794626400 | K992348 | 000 |
| H679462638S0 | K992348 | 000 |
| H6794626380 | K992348 | 000 |
| H679462636S0 | K992348 | 000 |
| H6794626360 | K992348 | 000 |
| H679462634S0 | K992348 | 000 |
| H679462646S0 | K992348 | 000 |
| H6794626480 | K992348 | 000 |
| H679462648S0 | K992348 | 000 |
| H679462667S0 | K992348 | 000 |
| H6794626670 | K992348 | 000 |
| H679462666S0 | K992348 | 000 |
| H6794626660 | K992348 | 000 |
| H6794626650 | K992348 | 000 |
| H679462660S0 | K992348 | 000 |
| H679462654S0 | K992348 | 000 |
| H6794626540 | K992348 | 000 |
| H679462652S0 | K992348 | 000 |
| H6794626520 | K992348 | 000 |
| H679462650S0 | K992348 | 000 |
| H6794626500 | K992348 | 000 |
| H6794626340 | K992348 | 000 |