The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Ioi 32 Tm Femoral Component.
Device ID | K822321 |
510k Number | K822321 |
Device Name: | IOI 32 TM FEMORAL COMPONENT |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | INTERMEDICS ORTHOPEDICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-03 |
Decision Date | 1982-08-20 |