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510(k) K100479

PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE by Arthrocare Corp. — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2010
Date Received
February 18, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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  • K101437 — SPEEDFIX SUTURE SYSTEM (October 29, 2010)
  • K102262 — ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL (October 21, 2010)

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