FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
8449–8472 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM...
K101229 · LPH
Zimmer, Inc.
Orthopedic · 214d
Cleared Dec 03, 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS
K101730 · KWZ
Zimmer, Inc.
Orthopedic · 168d
Cleared Dec 03, 2010
PATRIOT TRANSCONTINENTAL M SPACERS
K102313 · MAX
Globus Medical, Inc.
Orthopedic · 109d
Cleared Dec 03, 2010
MERETE LOCKING BONE PLATE SYSTEM II
K102688 · KTT
Merete Medical GmbH
Orthopedic · 77d
Cleared Dec 02, 2010
PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS
K101126 · MBI
Core Essence Orthopaedics, Inc.
Orthopedic · 224d
Cleared Dec 02, 2010
EVOLVE EPS ORTHOLOC
K102352 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 105d
Cleared Dec 02, 2010
CONSENSUS TAPERSET HIP SYSTEM
K102399 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 100d
Cleared Dec 02, 2010
LAMINOPLASY PLATING SYSTEM
K103284 · NQW
Aesculap Implant Systems, Inc.
Orthopedic · 27d
Cleared Dec 01, 2010
CONCORDE CURVE SYSTEM
K101923 · MAX
Depuy Spine
Orthopedic · 145d
Cleared Dec 01, 2010
NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
K102514 · NKB
Nuvasive, Inc.
Orthopedic · 91d
Cleared Nov 30, 2010
STAXX(R) XD SYSTEM
K102682 · MQP
Spine Wave, Inc.
Orthopedic · 74d
Cleared Nov 24, 2010
ARROW ANATOMICAL SHOULDER SYSTEM
K093599 · KWS
Fournitures Hospitalieres Industrie
Orthopedic · 369d
Cleared Nov 24, 2010
AXLE INTERSPINOUS FUSION SYSTEM
K101471 · KWP
X-Spine Systems, Inc.
Orthopedic · 181d
Cleared Nov 24, 2010
HTO PLATING SYSTEM
K102505 · HRS
Aesculap Implant Systems, LLC
Orthopedic · 84d
Cleared Nov 23, 2010
TRINITY ACETABULAR SYSTEM
K093472 · MEH
Corin USA
Orthopedic · 382d
Cleared Nov 23, 2010
LOCKING BONE SCREW MODEL HCQ04, HCZ04
K100721 · HWC
Changzhou Orthmar Medical Instrument...
Orthopedic · 253d
Cleared Nov 23, 2010
DEPUY RECLAIM REVISION HIP SYSTEM
K102080 · LZO
Depuy(Ireland)
Orthopedic · 120d
Cleared Nov 23, 2010
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM
K102343 · HWC
Emerge Medical
Orthopedic · 98d
Cleared Nov 23, 2010
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW
K102429 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Nov 22, 2010
CSTS SCREW
K093055 · HWC
Orthopro, LLC
Orthopedic · 418d
Cleared Nov 22, 2010
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT
K103104 · KWS
Howmedica Osteonics Corp.
Orthopedic · 33d
Cleared Nov 19, 2010
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS
K103124 · LPH
Stryker Corporation
Orthopedic · 28d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102555 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 71d
Cleared Nov 17, 2010
CD HORIZON SPINAL SYSTEM
K102807 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 50d