510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100457Substantially Equivalent

Opus Speedscrew System

ArthroCare Corporation, Irvine CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100457 is the FDA 510(k) clearance record for OPUS SPEEDSCREW SYSTEM, a class II device, cleared for Arthrocare Corp. on under FDA product code HWC (Screw, Fixation, Bone). FDA records list 149 510(k) clearances for Arthrocare Corp., from to . As of , FDA records show no recalls naming K100457.

Clearance record

Decision date
Received
(30 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Arthrocare Corp. 15285 Alton Pkwy., # 200, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HWC

Trailing 12 months
22 clearances under product code HWC in the twelve months to November 2026, May 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code HWC, trailing twelve months
MonthClearances
December 20251
January 20260
February 20260
March 20262
April 20263
May 20264
June 20262
July 20261
August 20263
September 20264
October 20262
November 20260