The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Cement Extraction Instrument Set.
| Device ID | K780135 |
| 510k Number | K780135 |
| Device Name: | CEMENT EXTRACTION INSTRUMENT SET |
| Classification | Chisel (osteotome) |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDG |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-01-24 |
| Decision Date | 1978-01-31 |