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 |