The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Tri-lock Modified Femoral Prosthesis.
Device ID | K872878 |
510k Number | K872878 |
Device Name: | TRI-LOCK MODIFIED FEMORAL PROSTHESIS |
Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Contact | Barry R Sisson |
Correspondent | Barry R Sisson DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
Product Code | KWL |
CFR Regulation Number | 888.3360 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-21 |
Decision Date | 1987-08-07 |