The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Hollywood, Pacifica, Redondo, Ventura.
Device ID | K082310 |
510k Number | K082310 |
Device Name: | HOLLYWOOD, PACIFICA, REDONDO, VENTURA |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
Contact | Jeff Brittan |
Correspondent | Jeff Brittan SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-13 |
Decision Date | 2008-11-10 |
Summary: | summary |