The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Anspach Minimal Access Spinal Attachment (masa) System.
| Device ID | K042783 |
| 510k Number | K042783 |
| Device Name: | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM |
| Classification | Drills, Burrs, Trephines & Accessories (simple, Powered) |
| Applicant | THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | William G Conety |
| Correspondent | William G Conety THE ANSPACH EFFORT, INC. 4500 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | HBE |
| CFR Regulation Number | 882.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-06 |
| Decision Date | 2004-12-17 |
| Summary: | summary |