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
11521–11544 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 08, 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Apr 02, 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 585d
Cleared Apr 02, 2004
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · KWQ
Depuyacromed
Orthopedic · 64d
Cleared Apr 01, 2004
OSTEOSORB TACK FIXATION SYSTEM
K030989 · JEY
Noviace Corporation
Orthopedic · 370d
Cleared Apr 01, 2004
SYNTHES AFS
K032534 · NQW
Synthes Spine
Orthopedic · 230d
Cleared Apr 01, 2004
KYPHX HV-R, MODEL C01A
K033801 · NDN
Kyphon, Inc.
Orthopedic · 115d
Cleared Mar 31, 2004
BIOCRYL RAPIDE INTERFERENCE SCREW
K032717 · HWC
Mitek Worldwide
Orthopedic · 211d
Cleared Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702 · MQP
Blackstone Medical, Inc.
Orthopedic · 127d
Cleared Mar 31, 2004
MERLIN SPINE SYSTEM
K033901 · NKB
Depuy Spine, Inc.
Orthopedic · 105d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · MNI
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · HWC
United States Surgical, A Division of...
Orthopedic · 23d
Cleared Mar 26, 2004
FIXION HIP SYSTEM
K032730 · JDI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 205d
Cleared Mar 26, 2004
ICON POLYAXIAL PEDICLE SCREW SYSTEM
K033090 · KWP
Alphatec Mfg., Inc.
Orthopedic · 179d
Cleared Mar 26, 2004
VERTEBRON SCP CERVICAL PLATE SYSTEM
K040003 · KWQ
Vertebron, Inc.
Orthopedic · 84d
Cleared Mar 26, 2004
MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
K040128 · HSD
Howmedica Osteonics Corp.
Orthopedic · 65d
Cleared Mar 26, 2004
ANTERIOR LUMBAR BUTTRESS SYSTEM
K040130 · KWQ
Seaspine
Orthopedic · 65d
Cleared Mar 26, 2004
CERASORB M ORTHO
K040216 · MQV
Curasan AG
Orthopedic · 56d
Cleared Mar 23, 2004
ELLYS AND AURYS VERTEBRAL BODY REPLACEMENTS
K033109 · MQP
Scient'X
Orthopedic · 175d
Cleared Mar 23, 2004
NEWMEDICAL MICRO BONE DISTRACTOR/FIXATOR
K040064 · KTT
Newmedical Technology, Inc.
Orthopedic · 70d
Cleared Mar 23, 2004
BONE-LOK HP WASHER
K040250 · HTN
Triage Medical, Inc.
Orthopedic · 50d
Cleared Mar 23, 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · KTT
Synthes (Usa)
Orthopedic · 48d
Cleared Mar 23, 2004
SUSTAIN RADIOLUCENT SPACER
K040284 · MQP
Globus Medical, Inc.
Orthopedic · 46d
Cleared Mar 23, 2004
TRIGEN TROCHANTERIC ANTEGRADE NAIL
K040462 · HSB
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 19, 2004
MODIFICATION TO VERTE-STACK
K040422 · MQP
Medtronic Sofamor Danek
Orthopedic · 30d