The following data is part of a premarket notification filed by Alliance Partners, Llc with the FDA for Nakoma Acp.
Device ID | K141993 |
510k Number | K141993 |
Device Name: | NAKOMA ACP |
Classification | Appliance, Fixation, Spinal Intervertebral Body |
Applicant | ALLIANCE PARTNERS, LLC 4600 E SHELBY DR Memphis, TN 38118 |
Contact | Kellen Hills |
Correspondent | Kellen Hills ALLIANCE PARTNERS, LLC 4600 E SHELBY DR Memphis, TN 38118 |
Product Code | KWQ |
CFR Regulation Number | 888.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-07-22 |
Decision Date | 2014-11-06 |
Summary: | summary |