The following data is part of a premarket notification filed by Innovative Spinal Technologies Inc with the FDA for Paramount Intervertebral Body Fusion Device.
| Device ID | K072120 |
| 510k Number | K072120 |
| Device Name: | PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | INNOVATIVE SPINAL TECHNOLOGIES INC 111 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Gina Yeh |
| Correspondent | Gina Yeh INNOVATIVE SPINAL TECHNOLOGIES INC 111 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-01 |
| Decision Date | 2007-10-11 |
| Summary: | summary |