The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Issys Lp Spinal Fixation System.
Device ID | K111099 |
510k Number | K111099 |
Device Name: | ISSYS LP SPINAL FIXATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
Contact | Saad Attiyah |
Correspondent | Saad Attiyah CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 Parsippany, NJ 07054 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
Subsequent Product Code | MNH |
Subsequent Product Code | MNI |
CFR Regulation Number | 888.3070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-04-20 |
Decision Date | 2011-05-05 |
Summary: | summary |