The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Stainless Steel Elastic Intramedullary Nail System.
| Device ID | K081452 |
| 510k Number | K081452 |
| Device Name: | SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Contact | Jill R Sherman |
| Correspondent | Jill R Sherman SYNTHES (USA) 1301 GOSHEN PKWY West Chester, PA 19380 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-23 |
| Decision Date | 2008-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792759050 | K081452 | 000 |
| H679275900 | K081452 | 000 |
| H6792759400 | K081452 | 000 |
| H6792759350 | K081452 | 000 |
| H6792759300 | K081452 | 000 |
| H6792759250 | K081452 | 000 |
| H6792759200 | K081452 | 000 |
| H6792759150 | K081452 | 000 |