The following data is part of a premarket notification filed by Stryker Spine with the FDA for Escalate Laminoplasty System.
| Device ID | K113802 |
| 510k Number | K113802 |
| Device Name: | ESCALATE LAMINOPLASTY SYSTEM |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07430 |
| Contact | Simona Voic |
| Correspondent | Simona Voic STRYKER SPINE 2 PEARL COURT Allendale, NJ 07430 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-23 |
| Decision Date | 2012-04-16 |
| Summary: | summary |