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
6553–6576 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 02, 2014
SIGNATURE PLANNER, SIGNATURE GUIDES
K140257 · MBH
Materialise NV
Orthopedic · 58d
Cleared Apr 01, 2014
N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAL IMPLANT, N8TIVE...
K133606 · MBI
ArthroCare Corporation
Orthopedic · 127d
Cleared Apr 01, 2014
MODIFIED DISTAL RADIUS PLATING SYSTEM
K133939 · HRS
Biomet
Orthopedic · 99d
Cleared Apr 01, 2014
VARIAX CLAVICLE HOOK PLATE
K140259 · HRS
Stryker Trauma AG
Orthopedic · 57d
Cleared Apr 01, 2014
IMBIBE NEEDLE
K140414 · LXH
Orthovita, Inc.
Orthopedic · 42d
Cleared Mar 31, 2014
SYNTHES SYNSONIC ULNA NAIL
K131984 · HSB
Synthes (Usa)
Orthopedic · 276d
Cleared Mar 31, 2014
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL...
K133721 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 116d
Cleared Mar 28, 2014
I-HIP TOTAL HIP SYSTEM
K132572 · LPH
Iconacy Orthopedic Implants, LLC
Orthopedic · 225d
Cleared Mar 28, 2014
PEEK FUSION IMPLANT
K133515 · HWC
Mtp Solutions, LLC
Orthopedic · 133d
Cleared Mar 28, 2014
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM
K133560 · JWH
Conformis, Inc.
Orthopedic · 128d
Cleared Mar 28, 2014
EXTREMITY MEDICAL HAMMERTOE DEVICE
K133636 · HWC
Extremity Medical, LLC
Orthopedic · 122d
Cleared Mar 28, 2014
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS)
K133940 · HRY
Biomet UK, Ltd.
Orthopedic · 95d
Cleared Mar 27, 2014
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC
K133455 · MAX
Pioneer Surgical Technology, Inc.
Orthopedic · 135d
Cleared Mar 27, 2014
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT...
K133930 · HRS
Flower Orthopedics Corporation
Orthopedic · 94d
Cleared Mar 27, 2014
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
K140106 · OVD
Renovis Surgical Technologies, Inc.
Orthopedic · 71d
Cleared Mar 26, 2014
COLLAGEN TENDON SHEET-DDI (CTS-DDI)
K140300 · OWY
Rotation Medical, Inc.
Orthopedic · 48d
Cleared Mar 25, 2014
SILEX SACROILIAC JOINT FUSION SYSTEM
K140079 · OUR
X-Spine Systems, Inc.
Orthopedic · 71d
Cleared Mar 25, 2014
CD HORIZON SPINAL SYSTEM
K140449 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 29d
Cleared Mar 25, 2014
VEGA KNEE SYSTEM
K140452 · JWH
Aesculap Implant Systems
Orthopedic · 29d
Cleared Mar 25, 2014
NAUTILUS SPINAL SYSTEM
K140457 · NKB
Life Spine, Inc.
Orthopedic · 29d
Cleared Mar 24, 2014
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW
K130550 · PHX
Encore Medical, L.P.
Orthopedic · 385d
Cleared Mar 24, 2014
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250 · JWJ
Integra LifeSciences Corporation
Orthopedic · 248d
Cleared Mar 24, 2014
PRODENSE BONE GRAFT SUBSTITUTE
K132656 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 210d
Cleared Mar 24, 2014
VARIAX DISTAL RADIUS PLATING SYSTEM
K133974 · HRS
Stryker Leibinger GmbH
Orthopedic · 88d