The following data is part of a premarket notification filed by Aurora Spine, Inc. with the FDA for Zip Mis Interspinous Fusion System.
| Device ID | K141317 |
| 510k Number | K141317 |
| Device Name: | ZIP MIS INTERSPINOUS FUSION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | AURORA SPINE, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton AURORA SPINE, INC. 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-20 |
| Decision Date | 2014-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5211040120430 | K141317 | 000 |
| B5211040080370 | K141317 | 000 |
| B5211040080390 | K141317 | 000 |
| B5211040080410 | K141317 | 000 |
| B5211040080430 | K141317 | 000 |
| B5211040100350 | K141317 | 000 |
| B5211040100370 | K141317 | 000 |
| B5211040100390 | K141317 | 000 |
| B5211040100410 | K141317 | 000 |
| B5211040100430 | K141317 | 000 |
| B5211040120350 | K141317 | 000 |
| B5211040120370 | K141317 | 000 |
| B5211040120390 | K141317 | 000 |
| B5211040120410 | K141317 | 000 |
| B5211040080350 | K141317 | 000 |