The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Andrews Remote Chuck Drill.
| Device ID | K831043 |
| 510k Number | K831043 |
| Device Name: | ANDREWS REMOTE CHUCK DRILL |
| Classification | Brace, Drill |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXY |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-31 |
| Decision Date | 1983-04-28 |