The following data is part of a premarket notification filed by Tornier with the FDA for Latitude Elbow Prothesis.
Device ID | K070787 |
510k Number | K070787 |
Device Name: | LATITUDE ELBOW PROTHESIS |
Classification | Prosthesis, Elbow, Semi-constrained, Cemented |
Applicant | TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
Contact | Mireille Lemery |
Correspondent | Mireille Lemery TORNIER 161 RUE LAVOISIER MONTBONNOT Saint-ismier Cedex, FR 38334 |
Product Code | JDB |
CFR Regulation Number | 888.3160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-03-22 |
Decision Date | 2007-08-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00846832012473 | K070787 | 000 |
00846832012466 | K070787 | 000 |
00846832012459 | K070787 | 000 |