510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230655Substantially Equivalent

PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw

Signature Orthopaedics Pty Limited, Lane Cove West, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230655 is the FDA 510(k) clearance record for PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw, a class II device, cleared for Signature Orthopaedics Pty, Ltd. on under FDA product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). FDA records list 45 510(k) clearances for Signature Orthopaedics Pty, Ltd., from to . As of , FDA records show no recalls naming K230655.

Clearance record

Decision date
Received
(55 days to decision)
Product code
MBI Fastener, Fixation, Nondegradable, Soft Tissue
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Signature Orthopaedics Pty, Ltd. 7 Sirius Rd., Lane Cove West, AU
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MBI

Trailing 12 months
31 clearances under product code MBI in the twelve months to October 2026, March 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code MBI, trailing twelve months
MonthClearances
November 20251
December 20252
January 20263
February 20261
March 20269
April 20261
May 20264
June 20261
July 20264
August 20262
September 20263
October 20260