The following data is part of a premarket notification filed by Stryker Spine with the FDA for Stryker Spine Avs Tl Peek Spacer.
| Device ID | K042571 |
| 510k Number | K042571 |
| Device Name: | STRYKER SPINE AVS TL PEEK SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2005-02-11 |
| Summary: | summary |