The following data is part of a premarket notification filed by Mahe Medical Gmbh with the FDA for Mahe Perfect Spine- Pedicle Screw System.
| Device ID | K110655 |
| 510k Number | K110655 |
| Device Name: | MAHE PERFECT SPINE- PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | MAHE MEDICAL GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, Bw, GR 78532 |
| Contact | Andrea Pecsi |
| Correspondent | Andrea Pecsi MAHE MEDICAL GMBH SCHWARZWALDSTRASSE 5 Tuttlingen, Bw, GR 78532 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-07 |
| Decision Date | 2011-10-27 |
| Summary: | summary |