Keos Lumbar IBFD

Intervertebral Fusion Device With Bone Graft, Lumbar

KEOS

The following data is part of a premarket notification filed by Keos with the FDA for Keos Lumbar Ibfd.

Pre-market Notification Details

• Device ID: K160631
• 510k Number: K160631
• Device Name: Keos Lumbar IBFD
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: KEOS 1824 COLONIAL VILLAGE LANE Lancaster, PA 17601
• Contact: Mark F. Schenk
• Correspondent: Mark F. Schenk; KEOS 1824 COLONIAL VILLAGE LANE Lancaster, PA 17601
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-07
• Decision Date: 2016-07-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B084KPS22310160	K160631	000
B084KPS22308150	K160631	000
B084KPS22308140	K160631	000
B084KPS22308130	K160631	000
B084KPS22308120	K160631	000
B084KPS22308110	K160631	000
B084KPS22308100	K160631	000
B084KPS22308090	K160631	000
B084KPS22308080	K160631	000
B084KPS22308160	K160631	000
B084KPS22310060	K160631	000
B084KPS22310070	K160631	000
B084KPS22310150	K160631	000
B084KPS22310140	K160631	000
B084KPS22310130	K160631	000
B084KPS22310120	K160631	000
B084KPS22310110	K160631	000
B084KPS22310100	K160631	000
B084KPS22310090	K160631	000
B084KPS22310080	K160631	000
B084KPS22308070	K160631	000
B084KPS22308060	K160631	000
B084KPS12310160	K160631	000
B084KPS12308140	K160631	000
B084KPS12308130	K160631	000
B084KPS12308120	K160631	000
B084KPS12308110	K160631	000
B084KPS12308100	K160631	000
B084KPS12308090	K160631	000
B084KPS12308080	K160631	000
B084KPS12308070	K160631	000
B084KPS12308150	K160631	000
B084KPS12308160	K160631	000
B084KPS12310060	K160631	000
B084KPS12310150	K160631	000
B084KPS12310140	K160631	000
B084KPS12310130	K160631	000
B084KPS12310120	K160631	000
B084KPS12310110	K160631	000
B084KPS12310100	K160631	000
B084KPS12310090	K160631	000
B084KPS12310080	K160631	000
B084KPS12308060	K160631	000
B084KTC12810060	K160631	000
B084KTS22810160	K160631	000
B084KTS12810150	K160631	000
B084KTS12810140	K160631	000
B084KTS12810130	K160631	000
B084KTS12810120	K160631	000
B084KTS12810110	K160631	000
B084KTS12810100	K160631	000
B084KTS12810090	K160631	000
B084KTS12810080	K160631	000
B084KTS12810160	K160631	000
B084KTS22810060	K160631	000
B084KTS22810070	K160631	000
B084KTS22810150	K160631	000
B084KTS22810140	K160631	000
B084KTS22810130	K160631	000
B084KTS22810120	K160631	000
B084KTS22810110	K160631	000
B084KTS22810100	K160631	000
B084KTS22810090	K160631	000
B084KTS22810080	K160631	000
B084KTS12810070	K160631	000
B084KTS12810060	K160631	000
B084KTC22810160	K160631	000
B084KTC12810150	K160631	000
B084KTC12810140	K160631	000
B084KTC12810130	K160631	000
B084KTC12810120	K160631	000
B084KTC12810110	K160631	000
B084KTC12810100	K160631	000
B084KTC12810090	K160631	000
B084KTC12810080	K160631	000
B084KTC12810160	K160631	000
B084KTC22810060	K160631	000
B084KTC22810070	K160631	000
B084KTC22810150	K160631	000
B084KTC22810140	K160631	000
B084KTC22810130	K160631	000
B084KTC22810120	K160631	000
B084KTC22810110	K160631	000
B084KTC22810100	K160631	000
B084KTC22810090	K160631	000
B084KTC22810080	K160631	000
B084KTC12810070	K160631	000