Atlas FDA

REVEL Spacers

FDA 510(k) clearance K180909 · decided 2018-12-18

Clearance details

K-number
K180909
Device name
REVEL Spacers
Applicant
Globus Medical, Inc.
Decision
Substantially Equivalent
Date received
2018-04-06
Decision date
2018-12-18
Days to decision
256 days
Clearance type
Traditional
Product code
ODP
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