The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Trochanteric Fixation Nail (tfn) System, Additional Helical Blades.
Device ID | K070294 |
510k Number | K070294 |
Device Name: | SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES |
Classification | Rod, Fixation, Intramedullary And Accessories |
Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
Contact | Sheri L Musgnung |
Correspondent | Sheri L Musgnung SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
Product Code | HSB |
CFR Regulation Number | 888.3020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-31 |
Decision Date | 2007-03-01 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679456650S0 | K070294 | 000 |
H679456310S0 | K070294 | 000 |
H679456300S0 | K070294 | 000 |