The following data is part of a premarket notification filed by Aurora Spine with the FDA for Zip Mis Interspinous Fusion System.
| Device ID | K133091 |
| 510k Number | K133091 |
| Device Name: | ZIP MIS INTERSPINOUS FUSION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | AURORA SPINE 331 H STREET NW, 12TH FL. Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton AURORA SPINE 331 H STREET NW, 12TH FL. 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 | 2013-09-30 |
| Decision Date | 2013-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B521001018ZIP0 | K133091 | 000 |
| B521001016ZIP0 | K133091 | 000 |
| B521001014ZIP0 | K133091 | 000 |
| B521001012ZIP0 | K133091 | 000 |
| B521001010ZIP0 | K133091 | 000 |
| B521001008ZIP0 | K133091 | 000 |