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
8209–8232 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 03, 2011
MAC MALE ADAPTER
K102843 · KTT
Biomet Trauma (Aka Ebi, LLC)
Orthopedic · 216d
Cleared May 03, 2011
BIOMET SPORTS MEDICINE STERNAL CLOSURE SYSTEM
K110039 · JDQ
Biomet Sports Medicine
Orthopedic · 117d
Cleared May 03, 2011
CORIN TRINITY ACETBULAR SYSTEM WITH HXLPE LINERS
K110087 · LZO
Corin USA
Orthopedic · 111d
Cleared May 03, 2011
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
K110976 · MQV
Nanotherapeutics, Inc.
Orthopedic · 26d
Cleared May 03, 2011
PICCOLO COMPOSITE NAILING SYSTEM
K111056 · HSB
CarboFix Orthopedics , Ltd.
Orthopedic · 15d
Cleared Apr 29, 2011
FORTROSS BONE VOID FILLER
K110561 · MQV
Pioneer Surgical Technology
Orthopedic · 60d
Cleared Apr 28, 2011
CUTTING EDGE SPINE INTERBODY FUSION DEVICE
K102957 · MAX
Cutting Edge Spine, LLC
Orthopedic · 205d
Cleared Apr 28, 2011
PCL TIGHTROPE
K110123 · HTY
Arthrex, Inc.
Orthopedic · 100d
Cleared Apr 27, 2011
AEQUALIS ASCEND MODULAR ANATOMIC SHOULDER SYSTEM
K110865 · KWS
Tornier, Inc.
Orthopedic · 29d
Cleared Apr 22, 2011
AVS ANCHOR-C CERVICAL CAGE SYSTEM
K102606 · OVE
Stryker Spine
Orthopedic · 224d
Cleared Apr 22, 2011
REVISION PROTHESIS
K110837 · JWH
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Apr 21, 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · HRS
Synthes (Usa)
Orthopedic · 93d
Cleared Apr 21, 2011
HELENA SYSTEM
K110177 · MAX
Royal Oak Medical Devices
Orthopedic · 90d
Cleared Apr 21, 2011
TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
K110787 · MQV
Orthogem Limited
Orthopedic · 31d
Cleared Apr 21, 2011
IFUSE IMPLANT SYSTEM
K110838 · OUR
SI-BONE, Inc.
Orthopedic · 27d
Cleared Apr 19, 2011
CONSERVE BIO FOAM SHELL
K110029 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 104d
Cleared Apr 18, 2011
INFILL INTERVERTEBRAL BODY FUSION DEVICE
K103729 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 117d
Cleared Apr 15, 2011
LANX SPINAL FIXATION SYSTEM
K103091 · KWP
Lanx, Inc.
Orthopedic · 178d
Cleared Apr 15, 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662 · LPH
Zimmer, Inc.
Orthopedic · 121d
Cleared Apr 14, 2011
NEWDEAL COMPRESSION PLATES
K093914 · HRS
Newdeal Sas
Orthopedic · 478d
Cleared Apr 14, 2011
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1
K110240 · OLO
Smith & Nephew, Inc.
Orthopedic · 77d
Cleared Apr 14, 2011
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K110368 · MQV
Novabone Products, LLC
Orthopedic · 65d
Cleared Apr 14, 2011
OPTERTRAK LOGIC PSC TIBIAL INSERT
K110547 · JWH
Exactech Sarasota
Orthopedic · 48d
Cleared Apr 13, 2011
ODRC-DYNAMIC HIP SCREW SYSTEM
K103015 · KTT
Orthopaedic Device Research Center
Orthopedic · 183d