The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Dvr Dorsal Plate, Dvr Lateral Plate, Dvr Ulna Plate.
Device ID | K140622 |
510k Number | K140622 |
Device Name: | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE |
Classification | Plate, Fixation, Bone |
Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Contact | Suzana Otano |
Correspondent | Suzana Otano BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-03-11 |
Decision Date | 2014-05-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887868132933 | K140622 | 000 |
00887868077104 | K140622 | 000 |
00887868077111 | K140622 | 000 |
00887868077142 | K140622 | 000 |
00887868077159 | K140622 | 000 |
00887868077166 | K140622 | 000 |
00887868129377 | K140622 | 000 |
00887868129384 | K140622 | 000 |
00887868129391 | K140622 | 000 |
00887868129407 | K140622 | 000 |
00887868129414 | K140622 | 000 |
00887868129421 | K140622 | 000 |
00887868129438 | K140622 | 000 |
00887868129445 | K140622 | 000 |
00887868129452 | K140622 | 000 |
00887868129469 | K140622 | 000 |
00887868132926 | K140622 | 000 |
00887868446078 | K140622 | 000 |