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
5665–5688 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 10, 2015
NuVasive CoRoent Lumbar System
K151472 · MAX
Nu Vasive, Incorporated
Orthopedic · 101d
Cleared Sep 10, 2015
Amendia Interbody Fusion Devices
K151322 · MAX
Amendia, Inc.
Orthopedic · 115d
Cleared Sep 09, 2015
SECURE-LOOP
K151601 · MBI
Xiros, Ltd.
Orthopedic · 89d
Cleared Sep 09, 2015
TGM Biolox delta Ceramic Heads
K150576 · LZO
Tgm Medical, Inc.
Orthopedic · 187d
Cleared Sep 04, 2015
Pyrenees Cervical Plate System
K152015 · KWQ
K2m, Inc.
Orthopedic · 45d
Cleared Sep 04, 2015
PRO-TOE Hammertoe Fixation System
K151838 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Sep 04, 2015
Xenco Medical Pedicle Screw System
K151733 · NKB
Xenco Medical, LLC
Orthopedic · 70d
Cleared Sep 04, 2015
NuVasive PEEK Corpectomy Railed System
K151538 · MQP
Nu Vasive, Incorporated
Orthopedic · 88d
Cleared Sep 04, 2015
TOTAL COMPRESSION PLATING (TCP) SYSTEM
K151442 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 98d
Cleared Sep 04, 2015
CrossTIE Intraosseous Fixation System
K151270 · HWC
Crossroads Extremity Systems, LLC
Orthopedic · 114d
Cleared Sep 04, 2015
Arcus Staple System
K151160 · JDR
Nextremity Solutions, Inc.
Orthopedic · 126d
Cleared Sep 04, 2015
JuggerKnot Soft Anchors
K150768 · MBI
Biomet Manufacturing Corp
Orthopedic · 164d
Cleared Sep 04, 2015
Synthetic Bone Graft (TriPore HA, TriPore BP90, TriPore BP15)
K150064 · MQV
Orthogem, Ltd.
Orthopedic · 234d
Cleared Sep 04, 2015
Navigated XIA 4.5 Polyaxial Screwdriver
K143597 · OLO
Stryker Corporate
Orthopedic · 260d
Cleared Sep 03, 2015
Exactech Optetrak Logic Enhanced Assembly
K152170 · JWH
Exactech, Inc.
Orthopedic · 30d
Cleared Sep 03, 2015
REDAPT¿ Revision Femoral System
K151902 · LZO
Smith & Nephew, Inc.
Orthopedic · 55d
Cleared Sep 03, 2015
SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System
K151885 · NKG
Depuy Synthes, Inc.
Orthopedic · 56d
Cleared Sep 03, 2015
Lotus Posterior Cervical/Thoracic Spinal System
K151705 · NKG
Spinal Elements, Inc.
Orthopedic · 71d
Cleared Sep 03, 2015
Klassic HD Hip System
K151440 · LPH
Total Joint Orthopedics, Inc.
Orthopedic · 97d
Cleared Sep 03, 2015
NuVasive PEEK Corpectomy System
K151167 · MQP
Nu Vasive, Incorporated
Orthopedic · 125d
Cleared Sep 03, 2015
Genesys Spine Apache Cervical Interbody Fusion System
K150812 · ODP
Genesys Spine
Orthopedic · 161d
Cleared Sep 03, 2015
Benefix Interspinous Fixation System
K143631 · PEK
U&I Corporation
Orthopedic · 255d
Cleared Sep 03, 2015
Exactech® Novation® Crown Cup®
K141960 · LPH
Exactech, Inc.
Orthopedic · 412d
Cleared Sep 02, 2015
Fortress Pedicular Fixation System
K152148 · NKB
Spineology, Inc.
Orthopedic · 30d