The following data is part of a premarket notification filed by Eminent Spine with the FDA for King Cobra Anterior Cervical Plate.
Device ID | K103068 |
510k Number | K103068 |
Device Name: | KING COBRA ANTERIOR CERVICAL PLATE |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | EMINENT SPINE 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Contact | Karen E Warden |
Correspondent | Karen E Warden EMINENT SPINE 8202 SHERMAN ROAD Chesterland, OH 44026 -2141 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-10-18 |
Decision Date | 2011-01-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M69520405764S1 | K103068 | 000 |
M69520405502S1 | K103068 | 000 |
M69520405482S1 | K103068 | 000 |
M69520405452S1 | K103068 | 000 |
M695204054317SM2Q | K103068 | 000 |
M695204054316SM2Q | K103068 | 000 |
M695204054315SM2Q | K103068 | 000 |
M695204054314SM2Q | K103068 | 000 |
M69520405422S1 | K103068 | 000 |
M695204054217SM2Q | K103068 | 000 |
M69520405533S1 | K103068 | 000 |
M69520405563S1 | K103068 | 000 |
M69520405724S1 | K103068 | 000 |
M69520405713S1 | K103068 | 000 |
M69520405684S1 | K103068 | 000 |
M69520405683S1 | K103068 | 000 |
M69520405653S1 | K103068 | 000 |
M69520405644S1 | K103068 | 000 |
M69520405623S1 | K103068 | 000 |
M69520405604S1 | K103068 | 000 |
M69520405593S1 | K103068 | 000 |
M695204054216SM2Q | K103068 | 000 |
M695204054215SM2Q | K103068 | 000 |
M695204054214SM2Q | K103068 | 000 |
M69520405282S1 | K103068 | 000 |
M69520405281S1 | K103068 | 000 |
M69520405261S1 | K103068 | 000 |
M69520405241S1 | K103068 | 000 |
M69520405221S1 | K103068 | 000 |
M69520405201S1 | K103068 | 000 |
M69520405181S1 | K103068 | 000 |
M69520405161S1 | K103068 | 000 |
M69520405141S1 | K103068 | 000 |
M69520405302S1 | K103068 | 000 |
M69520405332S1 | K103068 | 000 |
M695204054117SM2Q | K103068 | 000 |
M695204054116SM2Q | K103068 | 000 |
M695204054115SM2Q | K103068 | 000 |
M695204054114SM2Q | K103068 | 000 |
M695204054017SM2Q | K103068 | 000 |
M695204054015SM2Q | K103068 | 000 |
M695204054014SM2Q | K103068 | 000 |
M69520405392S1 | K103068 | 000 |
M69520405362S1 | K103068 | 000 |
M695204014016SM2Q | K103068 | 000 |
M69520405804S1 | K103068 | 000 |
B014KCP864 | K103068 | 000 |
B014KCP563 | K103068 | 000 |
B014KCP533 | K103068 | 000 |
B014KCP503 | K103068 | 000 |
B014KCP482 | K103068 | 000 |
B014KCP473 | K103068 | 000 |
B014KCP452 | K103068 | 000 |
B014KCP4316 | K103068 | 000 |
B014KCP4314 | K103068 | 000 |
B014KCP4312 | K103068 | 000 |
B014KCP593 | K103068 | 000 |
B014KCP604 | K103068 | 000 |
B014KCP844 | K103068 | 000 |
B014KCP804 | K103068 | 000 |
B014KCP764 | K103068 | 000 |
B014KCP724 | K103068 | 000 |
B014KCP713 | K103068 | 000 |
B014KCP683 | K103068 | 000 |
B014KCP653 | K103068 | 000 |
B014KCP644 | K103068 | 000 |
B014KCP623 | K103068 | 000 |
B014KCP422 | K103068 | 000 |
B014KCP4216 | K103068 | 000 |
B014KCP4214 | K103068 | 000 |
B014KCP282 | K103068 | 000 |
B014KCP281 | K103068 | 000 |
B014KCP261 | K103068 | 000 |
B014KCP241 | K103068 | 000 |
B014KCP221 | K103068 | 000 |
B014KCP201 | K103068 | 000 |
B014KCP181 | K103068 | 000 |
B014KCP161 | K103068 | 000 |
B014KCP141 | K103068 | 000 |
B014KCP302 | K103068 | 000 |
B014KCP332 | K103068 | 000 |
B014KCP4212 | K103068 | 000 |
B014KCP4116 | K103068 | 000 |
B014KCP4114 | K103068 | 000 |
B014KCP4112 | K103068 | 000 |
B014KCP4016 | K103068 | 000 |
B014KCP4014 | K103068 | 000 |
B014KCP4012 | K103068 | 000 |
B014KCP392 | K103068 | 000 |
B014KCP362 | K103068 | 000 |
M69520405844S1 | K103068 | 000 |