The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Staple Inserter-extractor For Arthros.
| Device ID | K830456 |
| 510k Number | K830456 |
| Device Name: | STAPLE INSERTER-EXTRACTOR FOR ARTHROS |
| Classification | Staple Driver |
| Applicant | INSTRUMENT MAKAR, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HXJ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-09 |
| Decision Date | 1983-03-09 |