510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230036Substantially Equivalent

Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230036 is the FDA 510(k) clearance record for Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand ), a class II device, cleared for Rti Surgical, Inc. on under FDA product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene). FDA records list 100 510(k) clearances for RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.), from to . As of , FDA records show no recalls naming K230036.

Clearance record

Decision date
Received
(178 days to decision)
Product code
GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Regulation
21 CFR 878.5000
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Rti Surgical, Inc. 11621 Research Cir., Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GAT

Trailing 12 months
5 clearances under product code GAT in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GAT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20261
September 20260
October 20260