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510(k) K003971

AXYA MEDICAL, INC. MODEL 1000 AXYALOOP BONE ANCHOR by Axya Medical, Inc. — Product Code MBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2001
Date Received
December 22, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Fixation, Nondegradable, Soft Tissue
Device Class
Class II
Regulation Number
888.3040
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)
  • 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)

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