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510(k) K051983

MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR by Axya Medical, Inc. — Product Code MAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2005
Date Received
July 22, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Biodegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Axya Medical, Inc.

  • K070773 — AXYA, MODEL 3000 AXYZLOOP TITANIUM BONE ANCHOR (October 11, 2007)
  • K070253 — AXYA SUTURE WELDING SYSTEM AND KIT (July 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)
  • 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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