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510(k) K070253

AXYA SUTURE WELDING SYSTEM AND KIT by Axya Medical, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2007
Date Received
January 26, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

Other clearances by Axya Medical, Inc.

  • K070773 — AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR (October 11, 2007)
  • K063194 — TUFFLEX POLYESTER SUTURE (December 4, 2006)
  • K060165 — AXYAFLEX POLYESTER SUTURE (September 1, 2006)
  • K060970 — AXYALOOP NONABSORBABLE BONE ANCHOR (July 5, 2006)
  • K052491 — AXYA MODEL 6500 AXYALOOP SELF-TAPPING BONE ANCHOR (October 7, 2005)
  • K051983 — MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (August 5, 2005)
  • K051250 — AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (June 9, 2005)
  • K041698 — AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR (October 5, 2004)
  • K022207 — AXYA MODEL 3000 AXYALOOP TITANIUM BONE ANCHOR SYSTEM (October 4, 2002)
  • K021929 — AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM (September 10, 2002)

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