Response BandLoc Spinal Fixation— 510(k) K161267

Name: FDA 510(k) clearance K161267
Creator: U.S. Food and Drug Administration
Published: 2016-08-11

Substantially Equivalent

OrthoPediatrics Corp.

FDA 510(k) clearance K161267 for Response BandLoc Spinal Fixation, Substantially Equivalent on 2016-08-11. Applicant: OrthoPediatrics Corp.. Device class: 2.

Clearance details

Applicant: OrthoPediatrics Corp.
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2016-05-05
Decision date: 2016-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWI

view all

K261374 — LigaPASS System2026-05-27
K253615 — Invictus Bands System2026-03-25
K222097 — OLYMPIC Deformity Band System2023-05-04
K230565 — HILINE Fixation System2023-04-20
K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24

More clearances from OrthoPediatrics Corp.

view all

K260323 — OrthoPediatrics® Locking Cannulated Blade Plate System2026-04-30
K252600 — Pediatric Plating Platform I Small-Mini2025-10-09
K251362 — PediFlex Flexible Nail System2025-06-24
K243963 — Pediatric Plating Platform Hip2025-04-29
K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur2025-04-01

Recalls naming K161267

K-number listed on FDA's recall record

Z-2321-2017 — Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.Class II·Terminated·OrthoPediatrics Corp·20170424

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161267.

Data sourced from openFDA. This site is unofficial and independent of the FDA.