The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Coonrad Iii Total Elbow.
Device ID | K883665 |
510k Number | K883665 |
Device Name: | COONRAD III TOTAL ELBOW |
Classification | Prosthesis, Elbow, Constrained, Cemented |
Applicant | ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Contact | Henry A Quello |
Correspondent | Henry A Quello ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
Product Code | JDC |
CFR Regulation Number | 888.3150 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-08-26 |
Decision Date | 1989-02-03 |