Atlas FDA

Strive

FDA 510(k) clearance K153704 · decided 2016-06-03

Clearance details

K-number
K153704
Device name
Strive
Applicant
Djo, LLC
Decision
Substantially Equivalent
Date received
2015-12-23
Decision date
2016-06-03
Days to decision
163 days
Clearance type
Abbreviated
Product code
GZJ
Device class
2
Regulation number
882.5890
Medical specialty
Neurology
Advisory committee
Neurology
Location
Vista, CA, 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
CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic) (P910066/S031)Djo, LLC2020-01-23
Bone Growth Stimulators (P910066/S030)Djo, LLC2019-08-02
OL1000/OL1000 SC and SpinaLogic Bone Growth Stimulators (P910066/S029)Djo, LLC2018-06-19
OL1000, OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S028)Djo, LLC2016-02-18
OL1000, OL1000 SC, SPINALOGIC (P910066/S027)Djo, LLC2015-07-24
OL1000/OL1000 SC AND SPINALOGIC BONE GROWTH STIMULATORS (P910066/S026)Djo, LLC2012-08-10
SPINALOGIC, OL1000, AND OL1000 SINGLE COIL BONE GROWTH STIMULATORS (P910066/S025)Djo, LLC2008-12-24
OL1000 DUAL COIL MEDIUM BONE GROWTH STIMULATION DEVICE (P910066/S024)Djo, LLC2007-12-10