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510(k) K992405

AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK) by Axya Medical, Inc. — Product Code GAW

K992405 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "AXYA MEDICAL INC, BONE ANCHOR SYSTEM AND KIT- (BAK)". The FDA issued a decision of Substantially Equivalent on September 22, 1999. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 1999
Date Received
July 20, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
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)

Other clearances for product code GAW

  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)

FDA data resources