The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Soribie Resurfacing Total Elbow System (proposed Name).
Device ID | K960087 |
510k Number | K960087 |
Device Name: | SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) |
Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Judy English |
Correspondent | Judy English WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | JDB |
CFR Regulation Number | 888.3160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-01-11 |
Decision Date | 1996-09-20 |
Summary: | summary |