The following data is part of a premarket notification filed by Synthes (usa), Llc with the FDA for Zero-p Natural Plate System.
Device ID | K152239 |
510k Number | K152239 |
Device Name: | Zero-P Natural Plate System |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | Synthes (USA), LLC 1051 Synthes Ave Monument, CO 80132 |
Contact | Beth Becotte |
Correspondent | Laura Bleyendaal DePuy Synthes 325 Paramount Drive Raynham, MA 02767 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-08-10 |
Decision Date | 2015-12-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H98103617014S0 | K152239 | 000 |
07612334097033 | K152239 | 000 |
07612334097026 | K152239 | 000 |
07612334097002 | K152239 | 000 |
07612334096999 | K152239 | 000 |
07612334096982 | K152239 | 000 |
07612334096975 | K152239 | 000 |
07612334096968 | K152239 | 000 |
07612334096951 | K152239 | 000 |
07612334096944 | K152239 | 000 |
07612334096920 | K152239 | 000 |
07612334096913 | K152239 | 000 |
07612334096890 | K152239 | 000 |
07612334096883 | K152239 | 000 |
07612334096876 | K152239 | 000 |
07612334096869 | K152239 | 000 |
07612334096746 | K152239 | 000 |
07612334097040 | K152239 | 000 |
07612334097057 | K152239 | 000 |
07612334096906 | K152239 | 000 |
07612334096722 | K152239 | 000 |
H98104617712S0 | K152239 | 000 |
H98104617711S0 | K152239 | 000 |
H98104617710S0 | K152239 | 000 |
H98104617709S0 | K152239 | 000 |
H98104617708S0 | K152239 | 000 |
H98104617707S0 | K152239 | 000 |
H98104617706S0 | K152239 | 000 |
07612334097132 | K152239 | 000 |
07612334097125 | K152239 | 000 |
07612334097118 | K152239 | 000 |
07612334097101 | K152239 | 000 |
07612334097088 | K152239 | 000 |
07612334097071 | K152239 | 000 |
07612334097064 | K152239 | 000 |
07612334096739 | K152239 | 000 |