Atlas FDA

FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers

FDA 510(k) clearance K171848 · decided 2017-12-21

Clearance details

K-number
K171848
Device name
FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
Applicant
Globus Medical, Inc.
Decision
Substantially Equivalent
Date received
2017-06-21
Decision date
2017-12-21
Days to decision
183 days
Clearance type
Traditional
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Audubon, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SECURE®-C Cervical Artificial Disc (P100003/S008)Globus Medical, Inc.2023-06-12
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S007)Globus Medical, Inc.2017-08-18
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S006)Globus Medical, Inc.2016-05-17
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S005)Globus Medical, Inc.2014-12-18
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S004)Globus Medical, Inc.2014-06-30
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S003)Globus Medical, Inc.2014-05-08
SECURE-C CERVICAL ARTIFICIAL DISC (P100003/S002)Globus Medical, Inc.2013-09-06
SECURE -C CERVICAL ARTIFICIAL DISC (P100003/S001)Globus Medical, Inc.2013-03-15