The following data is part of a premarket notification filed by Zavation, Llc with the FDA for Z-clamp Isp System.
| Device ID | K161016 |
| 510k Number | K161016 |
| Device Name: | Z-Clamp ISP System |
| Classification | Spinous Process Plate |
| Applicant | Zavation, LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Contact | James M Philips |
| Correspondent | Milton Phillips Zavation, LLC 220 Lakeland Parkway Flowood, MS 39232 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-11 |
| Decision Date | 2016-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842166181595 | K161016 | 000 |
| 00842166120952 | K161016 | 000 |
| 00842166120945 | K161016 | 000 |
| 00842166120938 | K161016 | 000 |
| 00842166120921 | K161016 | 000 |
| 00842166120914 | K161016 | 000 |
| 00842166120907 | K161016 | 000 |
| 00842166120891 | K161016 | 000 |
| 00842166120884 | K161016 | 000 |
| 00842166120877 | K161016 | 000 |
| 00842166120860 | K161016 | 000 |
| 00842166120853 | K161016 | 000 |
| 00842166120846 | K161016 | 000 |
| 00842166120969 | K161016 | 000 |
| 00842166120976 | K161016 | 000 |
| 00842166179400 | K161016 | 000 |
| 00842166179394 | K161016 | 000 |
| 00842166179387 | K161016 | 000 |
| 00842166179370 | K161016 | 000 |
| 00842166179363 | K161016 | 000 |
| 00842166121041 | K161016 | 000 |
| 00842166121034 | K161016 | 000 |
| 00842166121027 | K161016 | 000 |
| 00842166121010 | K161016 | 000 |
| 00842166121003 | K161016 | 000 |
| 00842166120990 | K161016 | 000 |
| 00842166120983 | K161016 | 000 |
| 00842166189317 | K161016 | 000 |