The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Tibial Baseplate/all Poly Patella.
Device ID | K934695 |
510k Number | K934695 |
Device Name: | NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Contact | Mitchell Dhority |
Correspondent | Mitchell Dhority INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-30 |
Decision Date | 1996-05-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024257757 | K934695 | 000 |