The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for In-fast Bone Screw System.
| Device ID | K011910 |
| 510k Number | K011910 |
| Device Name: | IN-FAST BONE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Contact | Elsa A Linke |
| Correspondent | Elsa A Linke AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
| Product Code | HWC |
| Subsequent Product Code | GAS |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-19 |
| Decision Date | 2001-07-13 |
| Summary: | summary |