The following data is part of a premarket notification filed by Astra Tech, Inc. with the FDA for Fixature Microthread Osseospeed, A Component Of The Astra Tech Implant System.
| Device ID | K053384 |
| 510k Number | K053384 |
| Device Name: | FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | ASTRA TECH, INC. 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson ASTRA TECH, INC. 11234 EL CAMINO REAL, STE 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-05 |
| Decision Date | 2006-03-24 |
| Summary: | summary |