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

Automated Intraoperative Spinal Rod Bending System

21 CFR 888.3070 / Orthopedic
FDA source (opens on fda.gov)

SIN is the FDA product code for Automated Intraoperative Spinal Rod Bending System, a class II device type, regulated under 21 CFR 888.3070. FDA's definition for this code 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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SIN
Device name
Automated Intraoperative Spinal Rod Bending System
FDA definition
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.
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SIN

By decision year
1 clearance under product code SIN with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SIN by decision year
YearClearances
20261

Applicants with the most clearances

Product code SIN
Applicants holding the most 510(k) clearances under product code SIN
ApplicantClearances
Alphatec Spine, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code