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 |