The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Os Spinal System.
| Device ID | K010911 |
| 510k Number | K010911 |
| Device Name: | MACROPORE OS SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-26 |
| Decision Date | 2001-07-20 |