The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Hydrosorb Spine System.
Device ID | K041105 |
510k Number | K041105 |
Device Name: | MACROPORE HYDROSORB SPINE SYSTEM |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
Contact | Kenneth Kleinhenz |
Correspondent | Kenneth 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 | 2004-04-30 |
Decision Date | 2004-07-28 |
Summary: | summary |