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510(k) K050292

SHARPOINT LUKENS BONE WAX by Surgical Specialties Corp — Product Code MTJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2005
Date Received
February 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wax, Bone
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

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  • K140227 — MONODERM SURGICAL SUTURE (February 28, 2014)
  • K080985 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) (April 23, 2008)
  • K080680 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE (March 21, 2008)
  • K071989 — QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL (August 6, 2007)
  • K072028 — QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM (August 3, 2007)
  • K063680 — SHARPOINT PDO (POLYDIOXANONE) SUTURES (May 9, 2007)
  • K053380 — CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE (January 18, 2006)
  • K052962 — OPTIMIZED BARB DESIGN (December 6, 2005)

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