The following data is part of a premarket notification filed by Spineology, Inc. with the FDA for Spineology Peek Bullet Lumbar Interbody Fusion Device.
| Device ID | K113030 |
| 510k Number | K113030 |
| Device Name: | SPINEOLOGY PEEK BULLET LUMBAR INTERBODY FUSION DEVICE |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SPINEOLOGY, INC. 7800 3RD ST N., SUITE 600 St. Paul, MN 55128 |
| Contact | Bryan Becker |
| Correspondent | Bryan Becker SPINEOLOGY, INC. 7800 3RD ST N., SUITE 600 St. Paul, MN 55128 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-12 |
| Decision Date | 2012-01-26 |
| Summary: | summary |