The following data is part of a premarket notification filed by Medicon Eg with the FDA for Medicon Spinal Spreading Systems.
| Device ID | K161680 |
| 510k Number | K161680 |
| Device Name: | MEDICON Spinal Spreading Systems |
| Classification | Retractor, Self-retaining, For Neurosurgery |
| Applicant | MEDICON EG GANSACKER 15 Tuttlingen, DE 78532 |
| Contact | Joachim Schmid |
| Correspondent | J. D. Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | GZT |
| CFR Regulation Number | 882.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-17 |
| Decision Date | 2017-03-24 |
| Summary: | summary |