The following data is part of a premarket notification filed by Biomet Spine & Bone Healing Technologies with the FDA for Solitarie Peek Anterior Spinal System-to Be Called Colitaire 35.
| Device ID | K120557 |
| 510k Number | K120557 |
| Device Name: | SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | BIOMET SPINE & BONE HEALING TECHNOLOGIES 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Contact | Margaret F Crowe |
| Correspondent | Margaret F Crowe BIOMET SPINE & BONE HEALING TECHNOLOGIES 100 INTERPACE PARKWAY Parsippany, NJ 07054 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-24 |
| Decision Date | 2012-03-19 |
| Summary: | summary |