The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Bone Screws.
| Device ID | K923841 |
| 510k Number | K923841 |
| Device Name: | BONE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C. 117 EAST ALLEGAN STREET Lansing, MI 48933 |
| Contact | Jerome F Abood |
| Correspondent | Jerome F Abood INSTRUMENT MAKAR, INC. C/O ABOOD,ABOOD & RHEAUME,P.C. 117 EAST ALLEGAN STREET Lansing, MI 48933 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1993-10-27 |