The following data is part of a premarket notification filed by Medicrea International with the FDA for C-jaws Cervical Compressive Staple.
Device ID | K133906 |
510k Number | K133906 |
Device Name: | C-JAWS CERVICAL COMPRESSIVE STAPLE |
Classification | Anterior Staple As Supplemental Fixation For Fusion |
Applicant | MEDICREA INTERNATIONAL 555 THIRTEENTH STREET NW Washington, DC 20004 |
Contact | John J Smith |
Correspondent | John J Smith MEDICREA INTERNATIONAL 555 THIRTEENTH STREET NW Washington, DC 20004 |
Product Code | PHQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-23 |
Decision Date | 2014-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03613720213994 | K133906 | 000 |
03613720214014 | K133906 | 000 |
03613720214106 | K133906 | 000 |
03613720214151 | K133906 | 000 |
03613720214168 | K133906 | 000 |
03613720214281 | K133906 | 000 |
03613720214298 | K133906 | 000 |
03613720192206 | K133906 | 000 |
03613720192213 | K133906 | 000 |
03613720192220 | K133906 | 000 |
03613720192237 | K133906 | 000 |
03613720192244 | K133906 | 000 |
03613720192251 | K133906 | 000 |
03613720192268 | K133906 | 000 |
03613720192275 | K133906 | 000 |
03613720192282 | K133906 | 000 |
03613720214007 | K133906 | 000 |