The following data is part of a premarket notification filed by Paradigm Spine, Llc with the FDA for Paradigm Interspinous Fusion Plate.
| Device ID | K093438 |
| 510k Number | K093438 |
| Device Name: | PARADIGM INTERSPINOUS FUSION PLATE |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Contact | Justin Eggleton |
| Correspondent | Justin Eggleton PARADIGM SPINE, LLC 1331 H STREET NW 12TH FLOOR Washington, DC 20005 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-04 |
| Decision Date | 2010-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260148897986 | K093438 | 000 |
| 04260148897474 | K093438 | 000 |
| 04260148890390 | K093438 | 000 |
| 04260148890383 | K093438 | 000 |
| 04260148890376 | K093438 | 000 |
| 04260148890369 | K093438 | 000 |
| 04260148890352 | K093438 | 000 |
| 04260148890345 | K093438 | 000 |
| 04260148890338 | K093438 | 000 |
| 04260148890321 | K093438 | 000 |
| 04260148890314 | K093438 | 000 |
| 04260148890307 | K093438 | 000 |
| 04260148890291 | K093438 | 000 |
| 04260148890284 | K093438 | 000 |
| 04260148890277 | K093438 | 000 |
| 04260148897481 | K093438 | 000 |
| 04260148897498 | K093438 | 000 |
| 04260148897504 | K093438 | 000 |
| 04260148897979 | K093438 | 000 |
| 04260148897962 | K093438 | 000 |
| 04260148897955 | K093438 | 000 |
| 04260148897948 | K093438 | 000 |
| 04260148897702 | K093438 | 000 |
| 04260148897696 | K093438 | 000 |
| 04260148897689 | K093438 | 000 |
| 04260148897672 | K093438 | 000 |
| 04260148897665 | K093438 | 000 |
| 04260148897658 | K093438 | 000 |
| 04260148897641 | K093438 | 000 |
| 04260148897634 | K093438 | 000 |
| 04260148897627 | K093438 | 000 |
| 04260148897511 | K093438 | 000 |
| 04260636670459 | K093438 | 000 |