Atlas FDA

RADIUS SPINAL SYSTEM

FDA 510(k) clearance K062270 · decided 2006-11-22

Clearance details

K-number
K062270
Device name
RADIUS SPINAL SYSTEM
Applicant
Stryker Spine
Decision
Substantially Equivalent
Date received
2006-08-07
Decision date
2006-11-22
Days to decision
107 days
Clearance type
Traditional
Product code
NKB
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Allendale, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker Radius Locking Caps, Catalog Number: 486610000, Manufactured by Stryker Spine SAS recall (Z-1239-2007)Stryker Spine2007-09-21

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