The following data is part of a premarket notification filed by Theken Spine Llc with the FDA for Instrument System For Endoscopic Spinal Surgery.
| Device ID | K121482 |
| 510k Number | K121482 |
| Device Name: | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY |
| Classification | Arthroscope |
| Applicant | THEKEN SPINE LLC 1153 MEDINA RD. Medina, OH 44256 -0000 |
| Contact | Dale Davison |
| Correspondent | Dale Davison THEKEN SPINE LLC 1153 MEDINA RD. Medina, OH 44256 -0000 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-18 |
| Decision Date | 2012-08-28 |
| Summary: | summary |