The following data is part of a premarket notification filed by Instrument Makar, Inc. with the FDA for Instrument Makar Perfix Interference Bone Screw.
| Device ID | K930980 |
| 510k Number | K930980 |
| Device Name: | INSTRUMENT MAKAR PERFIX INTERFERENCE BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | INSTRUMENT MAKAR, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan INSTRUMENT MAKAR, INC. C/O HOGAN & HARTSON 555 THIRTEENTH STREET, N.W. Washington, DC 20004 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-25 |
| Decision Date | 1994-02-10 |