Atlas FDA

AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS

FDA 510(k) clearance K110419 · decided 2011-07-28

Clearance details

K-number
K110419
Device name
AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
Applicant
Stryker Spine
Decision
Substantially Equivalent
Date received
2011-02-14
Decision date
2011-07-28
Days to decision
164 days
Clearance type
Traditional
Product code
GXZ
Device class
2
Regulation number
882.1350
Medical specialty
Neurology
Advisory committee
Neurology
Location
Allendale, NJ, 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
RAY TFC AND RAY TFC UNITE (P950019/S014)Stryker Spine2004-03-25
RAY TFC UNITE (P950019/S016)Stryker Spine2003-10-10
RAY THREADED FUSION CAGE (TFC) (P950019/S015)Stryker Spine2003-09-04
RAY TFC UNITE PRODUCT LINE (P950019/S013)Stryker Spine2003-07-15
RAY TFC DEVICE/RAY TFC UNITE DEVICE (P950019/S012)Stryker Spine2002-04-02
RAY THREADED FUSION CAGE(TFC-TM) DEVICE WITH INSTRUMENTATION (P950019/S011)Stryker Spine2000-03-30
RAY TFC DEVICE AND RAY TFC UNITE DEVICE (P950019/S009)Stryker Spine2000-03-02
RAY THREADED FUSION CAGE(TFC) (P950019/S010)Stryker Spine1999-12-01