The following data is part of a premarket notification filed by Orthopedic Sciences, Inc with the FDA for Hip Tool Implant.
Device ID | K022139 |
510k Number | K022139 |
Device Name: | HIP TOOL IMPLANT |
Classification | Plate, Fixation, Bone |
Applicant | ORTHOPEDIC SCIENCES, INC 4329 GRAYDON RD. San Diego, CA 92130 |
Contact | Floyd G Larson |
Correspondent | Floyd G Larson ORTHOPEDIC SCIENCES, INC 4329 GRAYDON RD. San Diego, CA 92130 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-07-02 |
Decision Date | 2002-09-23 |
Summary: | summary |