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
6769–6792 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 26, 2013
TRIATHLON TRITANIUM METAL-BACKED PATELLA
K132624 · MBH
Stryker Orthopaedics
Orthopedic · 96d
Cleared Nov 26, 2013
SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
K132740 · NQW
Spinefrontier, Inc.
Orthopedic · 84d
Cleared Nov 25, 2013
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
K132029 · OVE
Spinal USA
Orthopedic · 147d
Cleared Nov 25, 2013
ANAX 5.5 SPINAL SYSTEM
K132101 · MNH
U&I Corporation
Orthopedic · 140d
Cleared Nov 25, 2013
ARTHREX COMPRESSION FT SCREWS
K132217 · HWC
Arthrex, Inc.
Orthopedic · 131d
Cleared Nov 25, 2013
TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM
K132504 · KWP
Corelink, LLC
Orthopedic · 105d
Cleared Nov 25, 2013
CD HORIZON SPINAL SYSTEM
K132639 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 94d
Cleared Nov 25, 2013
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K132884 · NKB
Zimmer Spine, Inc.
Orthopedic · 73d
Cleared Nov 22, 2013
SP-FIX SPINOUS PROCESS FIXATION PLATE
K132191 · PEK
Globus Medical, Inc.
Orthopedic · 130d
Cleared Nov 22, 2013
CRESCENT SPINAL SYSTEM
K133216 · MAX
Medtronic Sofamor Danek, Inc.
Orthopedic · 35d
Cleared Nov 20, 2013
AFFIX II SPINOUS PROCESS PLATE SYSTEM
K132411 · PEK
Nu Vasive, Incorporated
Orthopedic · 110d
Cleared Nov 20, 2013
APEX SPINE SYSTEM
K132603 · NKB
Spinecraft, LLC
Orthopedic · 92d
Cleared Nov 20, 2013
EVEREST SPINAL SYSTEM
K132757 · MNI
K2m, Inc.
Orthopedic · 77d
Cleared Nov 20, 2013
EDGE ORTHOPAEDICS BITE COMPRESSION SCREW
K132893 · HWC
Icon Orthopaedic Concepts Dba Edge...
Orthopedic · 65d
Cleared Nov 19, 2013
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377 · KWD
Arthrosurface, Inc.
Orthopedic · 189d
Cleared Nov 19, 2013
A.L.P.S. CALCANEAL PLATING SYSTEM
K132898 · HRS
Biomet Manufacturing Corp
Orthopedic · 64d
Cleared Nov 18, 2013
LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5
K131782 · HRS
Aap Implantate AG
Orthopedic · 154d
Cleared Nov 18, 2013
INTEGRITY SPINE CORE SYSTEM
K132718 · ODP
Integrity Spine
Orthopedic · 80d
Cleared Nov 18, 2013
INTEGRA FACET FIXATION SYSTEM
K132859 · MRW
Seaspine, Inc.
Orthopedic · 67d
Cleared Nov 18, 2013
UNIVISE SPINOUS PROCESS FIXATION PLATE (35MM, 40MM)
K132968 · PEK
Stryker Spine
Orthopedic · 56d
Cleared Nov 18, 2013
FLOWER ANKLE PLATING SET
K133102 · HRS
Flower Orthopedics Corporation
Orthopedic · 49d
Cleared Nov 15, 2013
TENSYN BAND
K131850 · HTN
Dallen Medical, Inc.
Orthopedic · 147d
Cleared Nov 13, 2013
IDYS(TM) C
K130853 · ODP
Clariance
Orthopedic · 230d
Cleared Nov 12, 2013
SPECTRUM SPINE SPINOUS PROCESS DEVICE
K130066 · PEK
Spectrum Spine IP Holdings, LLC
Orthopedic · 306d