The following data is part of a premarket notification filed by Spinal Concepts, Inc. with the FDA for Harmony Port System, Model 1907 Series.
| Device ID | K050706 |
| 510k Number | K050706 |
| Device Name: | HARMONY PORT SYSTEM, MODEL 1907 SERIES |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch SPINAL CONCEPTS, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-18 |
| Decision Date | 2005-04-15 |
| Summary: | summary |