The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Congruent Tibial Insert With Screw.
Device ID | K931651 |
510k Number | K931651 |
Device Name: | NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Contact | Joann Ringer |
Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
Product Code | JWH |
CFR Regulation Number | 888.3560 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-05 |
Decision Date | 1994-07-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00889024257627 | K931651 | 000 |