The following data is part of a premarket notification filed by Medicine Lodge, Inc. with the FDA for Medicinelodge, Inc. Set Screw.
Device ID | K961905 |
510k Number | K961905 |
Device Name: | MEDICINELODGE, INC. SET SCREW |
Classification | Screw, Fixation, Bone |
Applicant | MEDICINE LODGE, INC. 152 SOUTH 600 WEST Logan, UT 84321 |
Contact | Wade F Allin |
Correspondent | Wade F Allin MEDICINE LODGE, INC. 152 SOUTH 600 WEST Logan, UT 84321 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-16 |
Decision Date | 1996-08-06 |
Summary: | summary |