The following data is part of a premarket notification filed by Ldr Spine, Usa, Inc. with the FDA for Interbridge Interspinous Posterior Fixation System.
| Device ID | K133363 |
| 510k Number | K133363 |
| Device Name: | INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM |
| Classification | Spinous Process Plate |
| Applicant | LDR SPINE, USA, INC. 4628 NORTHPARK DRIVE Colorado Spring, CO 80918 |
| Contact | Meredith May |
| Correspondent | Meredith May LDR SPINE, USA, INC. 4628 NORTHPARK DRIVE Colorado Spring, CO 80918 |
| Product Code | PEK |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-01 |
| Decision Date | 2014-03-07 |
| Summary: | summary |