The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Modified Skeletal Traction Pin.
Device ID | K761088 |
510k Number | K761088 |
Device Name: | DEPUY MODIFIED SKELETAL TRACTION PIN |
Classification | Component, Traction, Invasive |
Applicant | DEPUY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JEC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-22 |
Decision Date | 1976-12-17 |