The following data is part of a premarket notification filed by X-spine Systems, Inc with the FDA for Zygafix Spinal Facet Screw System.
| Device ID | K123932 |
| 510k Number | K123932 |
| Device Name: | ZYGAFIX SPINAL FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg, OH 45342 |
| Contact | David Kirschman |
| Correspondent | David Kirschman X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg, OH 45342 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-20 |
| Decision Date | 2013-05-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M697X07600381 | K123932 | 000 |
| M697X07600211 | K123932 | 000 |
| M697X07600221 | K123932 | 000 |
| M697X07600231 | K123932 | 000 |
| M697X07600241 | K123932 | 000 |
| M697X07600291 | K123932 | 000 |
| M697X07600301 | K123932 | 000 |
| M697X07600311 | K123932 | 000 |
| M697X07600321 | K123932 | 000 |
| M697X07600331 | K123932 | 000 |
| M697X07600341 | K123932 | 000 |
| M697X07600371 | K123932 | 000 |
| M697X07600201 | K123932 | 000 |