The following data is part of a premarket notification filed by Medicine Lodge, Inc. with the FDA for Mli Interference Screw.
Device ID | K953350 |
510k Number | K953350 |
Device Name: | MLI INTERFERENCE SCREW |
Classification | Screw, Fixation, Bone |
Applicant | MEDICINE LODGE, INC. 152 SOUTH 600 WEST Logan, UT 84321 |
Contact | Alan Chervitz |
Correspondent | Alan Chervitz MEDICINE LODGE, INC. 152 SOUTH 600 WEST Logan, UT 84321 |
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 | 1995-07-17 |
Decision Date | 1996-01-30 |