The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Lcp Proximal Femur Hook Plates.
Device ID | K032032 |
510k Number | K032032 |
Device Name: | SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES |
Classification | Plate, Fixation, Bone |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
Contact | Lisa M Boyle |
Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 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 | 2003-07-01 |
Decision Date | 2003-09-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H679242128S0 | K032032 | 000 |
H679242120S0 | K032032 | 000 |
H6792421210 | K032032 | 000 |
H679242121S0 | K032032 | 000 |
H6792421220 | K032032 | 000 |
H679242122S0 | K032032 | 000 |
H6792421230 | K032032 | 000 |
H679242123S0 | K032032 | 000 |
H6792421240 | K032032 | 000 |
H679242124S0 | K032032 | 000 |
H6792421250 | K032032 | 000 |
H679242125S0 | K032032 | 000 |
H6792421260 | K032032 | 000 |
H679242126S0 | K032032 | 000 |
H6792421270 | K032032 | 000 |
H679242127S0 | K032032 | 000 |
H6792421280 | K032032 | 000 |
H6792421200 | K032032 | 000 |