510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071261Substantially Equivalent

Isobar Semi-Rigid Dual Dampener

Scient'X, Maitland FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071261 is the FDA 510(k) clearance record for ISOBAR SEMI-RIGID DUAL DAMPENER, a class II device, cleared for Scient'X on under FDA product code NQP (Posterior Metal/Polymer Spinal System, Fusion). FDA's definition for product code NQP reads: "This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the...". FDA records list 12 510(k) clearances for Scient'X, from to . As of , FDA records show no recalls naming K071261.

Clearance record

Decision date
Received
(349 days to decision)
Product code
NQP Posterior Metal/Polymer Spinal System, Fusion
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Scient'X 1015 Maitland Center Commons, Maitland FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQP

Trailing 12 months

FDA records hold no clearances under product code NQP in the trailing twelve months.

FDA records show no clearances under product code NQP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NQP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260