Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

41 results for "OrthoPediatrics Corp."
1–24 of 41
Search insights Median review: 86d Cleared: 100% Top manufacturer: OrthoPediatrics Corp. Lead specialty: Orthopedic
Cleared Sep 24, 2026
Pediatric Nailing Platform Femur
K261345 · HSB
OrthoPediatrics Corp.
Orthopedic · 154d
Cleared Apr 30, 2026
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · HRS
OrthoPediatrics Corp.
Orthopedic · 90d
Cleared Oct 09, 2025
Pediatric Plating Platform I Small-Mini
K252600 · HRS
OrthoPediatrics Corp.
Orthopedic · 52d
Cleared Jun 24, 2025
PediFlex™ Flexible Nail System
K251362 · HTY
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Apr 29, 2025
Pediatric Plating Platform Hip
K243963 · HRS
OrthoPediatrics Corp.
Orthopedic · 127d
Cleared Apr 01, 2025
Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur
K250623 · HSB
OrthoPediatrics Corp.
Orthopedic · 29d
Cleared Mar 14, 2025
VerteGlide Spinal Growth Guidance System
K241816 · PGM
OrthoPediatrics Corp.
Orthopedic · 263d
Cleared Mar 07, 2025
Orthex External Fixation System
K243798 · KTT
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Jan 20, 2024
RESPONSE™ Rib and Pelvic System
K233105 · MDI
OrthoPediatrics Corp.
Orthopedic · 115d
Cleared Aug 21, 2023
Pediatric Nailing Platform Tibia
K231266 · HSB
OrthoPediatrics Corp.
Orthopedic · 111d
Cleared Mar 23, 2023
RESPONSE 5.5/6.0 Cannulated Screw System
K222105 · NKB
OrthoPediatrics Corp.
Orthopedic · 248d
Cleared Feb 10, 2023
Orthex External Fixation System
K223786 · KTT
OrthoPediatrics Corp.
Orthopedic · 53d
Cleared Jul 20, 2022
Pediatric Nailing Platform Femur
K220679 · HSB
OrthoPediatrics Corp.
Orthopedic · 134d
Cleared Apr 08, 2022
Drive Rail System
K220809 · KTT
OrthoPediatrics Corp.
Orthopedic · 18d
Cleared Feb 04, 2021
RESPONSE Navigation Instruments
K203573 · OLO
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared Jan 29, 2021
PediFlex Flexible Nail System
K201838 · HTY
OrthoPediatrics Corp.
Orthopedic · 211d
Cleared Mar 24, 2020
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0...
K193100 · NKB
OrthoPediatrics Corp.
Orthopedic · 137d
Cleared Mar 16, 2020
Response BandLoc Spinal Fixation
K200097 · OWI
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Oct 09, 2019
Pediatric Nailing PlatformFemur
K190321 · HSB
OrthoPediatrics Corp.
Orthopedic · 238d
Cleared Aug 06, 2019
OrthoPediatrics PediFoot Deformity Corrections System
K190992 · HRS
OrthoPediatrics Corp.
Orthopedic · 113d
Cleared Jul 05, 2019
OrthoPediatrics Cannulated Screw System
K190324 · HWC
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared Sep 18, 2018
Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine...
K181390 · NKB
OrthoPediatrics Corp.
Orthopedic · 112d
Cleared Aug 24, 2017
OrthoPediatrics Titanium PediPlates® System
K171173 · HRS
OrthoPediatrics Corp.
Orthopedic · 125d
Cleared Sep 27, 2016
OrthoPediatrics Locking Proximal Femur System Cortical Screws
K162307 · HRS
OrthoPediatrics Corp.
Orthopedic · 41d