510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253216Substantially Equivalent

IntraOp Alignment System; CONTOUR3D Bending System

Alphatec Spine, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253216 is the FDA 510(k) clearance record for IntraOp Alignment System; CONTOUR3D Bending System, a class II device, cleared for Alphatec Spine, Inc. on under FDA product code SIN (Automated Intraoperative Spinal Rod Bending System). FDA's definition for product code SIN reads: "A rod bending system is intended to be used to intraoperatively bend thoracolumbosacral pedicle screw system rods by executing bending instructions in accordance with a user-defined rod plan to generate a patient-matched rod". FDA records list 121 510(k) clearances for Alphatec Spine, Inc., from to . As of , FDA records show no recalls naming K253216.

Clearance record

Decision date
Received
(269 days to decision)
Product code
SIN Automated Intraoperative Spinal Rod Bending System
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Alphatec Spine, Inc. 1950 Camino Vida Roble, Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SIN

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