The following data is part of a premarket notification filed by Synthes Spine with the FDA for Modification To Synthes Universal Spinal System.
Device ID | K990745 |
510k Number | K990745 |
Device Name: | MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM |
Classification | Orthosis, Spinal Pedicle Fixation |
Applicant | SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Contact | J0nathan Gilbert |
Correspondent | J0nathan Gilbert SYNTHES SPINE P.O. BOX 0548 1690 RUSSELL ROAD Paoli, PA 19301 |
Product Code | MNI |
Subsequent Product Code | KWP |
Subsequent Product Code | MNH |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-08 |
Decision Date | 1999-03-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H9814982050 | K990745 | 000 |
H9814982040 | K990745 | 000 |
H9814982030 | K990745 | 000 |