The following data is part of a premarket notification filed by Lanx, Llc with the FDA for Lanx Deformity System.
| Device ID | K071633 |
| 510k Number | K071633 |
| Device Name: | LANX DEFORMITY SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | LANX, LLC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19102 |
| Contact | Janice Hogan |
| Correspondent | Janice Hogan LANX, LLC 1835 MARKET STREET, 28TH FLOOR Philadelphia, PA 19102 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-14 |
| Decision Date | 2007-08-15 |
| Summary: | summary |