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510(k) K230036

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ) by Rti Surgical, Inc. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
December 27, 2022
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 Rti Surgical, Inc.

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  • K241555 — Moldable Bone Void Filler and Moldable Bone Void Filler + CCC (February 21, 2025)
  • K172343 — Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology (October 23, 2017)
  • K163673 — Fortilink™-C with TETRAfuse™ 3D Technology (May 23, 2017)
  • K142070 — FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS (October 27, 2014)
  • K132850 — BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE P (March 31, 2014)

Other clearances for product code GAT

  • K254188 — Meniscus Versaflex (February 19, 2026)
  • K253145 — Pre-Sutured Tendon (October 22, 2025)
  • K253024 — ProZip Knotless Implant (October 16, 2025)
  • K252225 — PowerKnot High Strength Sutures (September 12, 2025)
  • K252201 — HS Fiber (August 13, 2025)
  • K242201 — HyperSuture White/Green Extension Line (March 27, 2025)
  • K241376 — HyperSuture All Blue Extension Line (August 9, 2024)
  • K234079 — HyperSuture Extension Line (May 10, 2024)
  • K231163 — HS Fiber Sutures (January 5, 2024)
  • K230311 — HyperSuture (November 24, 2023)