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."
25–41 of 41
Search insights Median review: 86d Cleared: 100% Top manufacturer: OrthoPediatrics Corp. Lead specialty: Orthopedic
Cleared Aug 11, 2016
Response BandLoc Spinal Fixation
K161267 · OWI
OrthoPediatrics Corp.
Orthopedic · 98d
Cleared Mar 23, 2016
Response 5.5 Spine System
K160466 · NKB
OrthoPediatrics Corp.
Orthopedic · 33d
Cleared May 22, 2015
Response 5.5/6.0 Spine System
K150600 · NKB
OrthoPediatrics Corp.
Orthopedic · 73d
Cleared Jul 29, 2014
PEDILOC FRAGMENT SYSTEM
K140431 · HRS
OrthoPediatrics Corp.
Orthopedic · 159d
Cleared Jun 20, 2013
ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM
K130217 · MBI
OrthoPediatrics Corp.
Orthopedic · 142d
Cleared May 08, 2013
RESPONSE SPINE SYSTEM
K130655 · OSH
OrthoPediatrics Corp.
Orthopedic · 57d
Cleared Jun 19, 2012
OP SPINE SYSTEM
K121250 · OSH
OrthoPediatrics Corp.
Orthopedic · 55d
Cleared Apr 16, 2012
OP SPINE SYSTEM
K120291 · OSH
OrthoPediatrics Corp.
Orthopedic · 76d
Cleared Aug 05, 2011
ORTHOPEDIATRICS BLADE PLATE SYSTEM
K110959 · HRS
OrthoPediatrics Corp.
Orthopedic · 122d
Cleared Jun 17, 2011
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
K111086 · HRS
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared May 17, 2010
ORTHOPEDIATRICS PEDILOC TIBIA PLATE SYSTEM
K100240 · HRS
OrthoPediatrics Corp.
Orthopedic · 110d
Cleared Apr 24, 2009
PEDIPLATES
K090666 · HRS
OrthoPediatrics Corp.
Orthopedic · 42d
Cleared Mar 11, 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · HSB
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Jan 30, 2009
ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEM
K083286 · HRS
OrthoPediatrics Corp.
Orthopedic · 86d
Cleared Nov 25, 2008
ORTHOPEDIATRICS BONE SCREWS
K082949 · HWC
OrthoPediatrics Corp.
Orthopedic · 54d
Cleared Oct 17, 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · HTY
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Jul 22, 2008
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407 · HRS
OrthoPediatrics Corp.
Orthopedic · 64d