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 |