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 | K140715 |
| 510k Number | K140715 |
| 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 | Justi N Eggleton |
| Correspondent | Justi N 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-21 |
| Decision Date | 2014-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B5211030180450 | K140715 | 000 |
| B5211030080400 | K140715 | 000 |
| B5211030080350 | K140715 | 000 |
| B521001016MZIP0 | K140715 | 000 |
| B521001014SZIP0 | K140715 | 000 |
| B521001014MZIP0 | K140715 | 000 |
| B521001012SZIP0 | K140715 | 000 |
| B521001012MZIP0 | K140715 | 000 |
| B521001010SZIP0 | K140715 | 000 |
| B521001010MZIP0 | K140715 | 000 |
| B521001008SZIP0 | K140715 | 000 |
| B5211030080450 | K140715 | 000 |
| B5211030100350 | K140715 | 000 |
| B5211030160450 | K140715 | 000 |
| B5211030160400 | K140715 | 000 |
| B5211030140450 | K140715 | 000 |
| B5211030140400 | K140715 | 000 |
| B5211030140350 | K140715 | 000 |
| B5211030120450 | K140715 | 000 |
| B5211030120400 | K140715 | 000 |
| B5211030120350 | K140715 | 000 |
| B5211030100450 | K140715 | 000 |
| B5211030100400 | K140715 | 000 |
| B521001008MZIP0 | K140715 | 000 |