The following data is part of a premarket notification filed by Apogee Orthosolutions with the FDA for Monster Screw System.
Device ID | K124027 |
510k Number | K124027 |
Device Name: | MONSTER SCREW SYSTEM |
Classification | Screw, Fixation, Bone |
Applicant | APOGEE ORTHOSOLUTIONS PO BOX 566 Chesterland, OH 44026 -2141 |
Contact | Karen E Warden, Phd |
Correspondent | Karen E Warden, Phd APOGEE ORTHOSOLUTIONS PO BOX 566 Chesterland, OH 44026 -2141 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-12-28 |
Decision Date | 2013-04-05 |
Summary: | summary |