The following data is part of a premarket notification filed by Stryker Spine with the FDA for Lite Decompression System- Light Cable Model 48089999.
| Device ID | K122637 |
| 510k Number | K122637 |
| Device Name: | LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999 |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Tina Mornak |
| Correspondent | Tina Mornak STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2012-11-01 |
| Summary: | summary |