The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Os Reconstruction.
Device ID | K024169 |
510k Number | K024169 |
Device Name: | MACROPORE OS RECONSTRUCTION |
Classification | Mesh, Surgical, Metal |
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 | EZX |
Subsequent Product Code | HRS |
Subsequent Product Code | HWC |
Subsequent Product Code | MAI |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-18 |
Decision Date | 2003-07-01 |
Summary: | summary |