The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Pathway Ivb/vbr.
| Device ID | K092904 |
| 510k Number | K092904 |
| Device Name: | PATHWAY IVB/VBR |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
| Contact | Saad Attiyah |
| Correspondent | Saad Attiyah CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2009-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840916113094 | K092904 | 000 |
| 00840916112950 | K092904 | 000 |
| 00840916112967 | K092904 | 000 |
| 00840916112974 | K092904 | 000 |
| 00840916112981 | K092904 | 000 |
| 00840916112998 | K092904 | 000 |
| 00840916113001 | K092904 | 000 |
| 00840916113018 | K092904 | 000 |
| 00840916113025 | K092904 | 000 |
| 00840916113032 | K092904 | 000 |
| 00840916113049 | K092904 | 000 |
| 00840916113056 | K092904 | 000 |
| 00840916113063 | K092904 | 000 |
| 00840916113070 | K092904 | 000 |
| 00840916113087 | K092904 | 000 |
| 00840916112943 | K092904 | 000 |