The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Aleutian Ibf System.
Device ID | K133614 |
510k Number | K133614 |
Device Name: | ALEUTIAN IBF SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | K2M, INC. 751 MILLER DR SE Leesburg, VA 22066 |
Contact | Nancy Giezen |
Correspondent | Nancy Giezen K2M, INC. 751 MILLER DR SE Leesburg, VA 22066 |
Product Code | MAX |
Subsequent Product Code | MQP |
Subsequent Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-11-25 |
Decision Date | 2014-04-03 |
Summary: | summary |