The following data is part of a premarket notification filed by Stryker Spine with the FDA for Reflex Hybrid Acp System.
| Device ID | K062310 |
| 510k Number | K062310 |
| Device Name: | REFLEX HYBRID ACP SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Simona Voic |
| Correspondent | Simona Voic STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-08 |
| Decision Date | 2006-08-18 |
| Summary: | summary |