510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K032966Substantially Equivalent

The Answer Screw Supplementation System

Simplicity Orthopedic Solutions, LLC, North Andover MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K032966 is the FDA 510(k) clearance record for THE ANSWER SCREW SUPPLEMENTATION SYSTEM, a class II device, cleared for Simplicity Orthopedic Solutions, LLC on under FDA product code HWC (Screw, Fixation, Bone). FDA records list one 510(k) clearance for Simplicity Orthopedic Solutions, LLC. As of , FDA records show no recalls naming K032966.

Clearance record

Decision date
Received
(112 days to decision)
Product code
HWC Screw, Fixation, Bone
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Simplicity Orthopedic Solutions, LLC 15 Woodberry Ln., North Andover MA
510(k) summary
Statement
Third party review
No

Clearances, product code HWC

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