The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Pathway Avid.
| Device ID | K111726 |
| 510k Number | K111726 |
| Device Name: | PATHWAY AVID |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
| Contact | David Drumfield |
| Correspondent | David Drumfield CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2012-02-06 |
| Summary: | summary |