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 |