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
7897–7920 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 08, 2011
ZAVATION CERVICAL PLATE SYSTEM
K112533 · KWQ
Zavation, LLC
Orthopedic · 101d
Cleared Dec 08, 2011
MODIFIED ROG SUTURE ANCHOR
K112991 · MBI
Rog Sports Medicine, Inc.
Orthopedic · 63d
Cleared Dec 08, 2011
EXACTECH EQUINOXE CAGE GLENOIDS
K113309 · KWS
Exactech, Inc.
Orthopedic · 30d
Cleared Dec 07, 2011
ATHENA PEDICLE SCREW SYSTEM
K110046 · NKB
Royal Oak Medical Devices
Orthopedic · 335d
Cleared Dec 06, 2011
ASCENSION ATLAS HUMERAL PLATING SYSTEM
K110700 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 267d
Cleared Dec 06, 2011
DISCO SUBTALAR IMPLANT
K111834 · HWC
Trilliant Surgical, Ltd.
Orthopedic · 160d
Cleared Dec 06, 2011
SPARTAN S3 FACET SYSTEM
K113011 · MRW
Amendia, Inc.
Orthopedic · 56d
Cleared Dec 05, 2011
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
K111667 · JDS
Synthes (Usa)
Orthopedic · 174d
Cleared Dec 05, 2011
BENDINI(TM) SPINAL ROD BENDING SYSTEM
K111811 · OLO
Nuvasive, Inc.
Orthopedic · 161d
Cleared Dec 05, 2011
SYNTHES CORTICAL SCREWS
K112583 · HWC
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Dec 05, 2011
AXLE PEEK INTERSPINOUS FUSION SYSTEM
K112592 · KWP
X-Spine Systems, Inc.
Orthopedic · 89d
Cleared Dec 02, 2011
APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)
K112779 · LPH
Omnlife Science
Orthopedic · 67d
Cleared Dec 01, 2011
ACCULIF TL-PEEK IBF CAGE
K112095 · MAX
Coalign Innovations, Inc.
Orthopedic · 132d
Cleared Dec 01, 2011
LATERAL BUTTON
K112296 · MBI
T.A.G. Medical Products Corporation,...
Orthopedic · 114d
Cleared Nov 30, 2011
ALAMO C
K112361 · ODP
Alliance Partners, LLC
Orthopedic · 105d
Cleared Nov 29, 2011
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
K111272 · OVE
Rhausler, Inc.
Orthopedic · 209d
Cleared Nov 29, 2011
BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
K111908 · HWC
Biomet Microfixation, Inc.
Orthopedic · 147d
Cleared Nov 28, 2011
RAPTOR FACET FIXATION SYSTEM
K110170 · MRW
Alphatec Spine, Inc.
Orthopedic · 312d
Cleared Nov 28, 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · HSB
Synthes USA Products, LLC
Orthopedic · 146d
Cleared Nov 23, 2011
TRABECULAR METAL (TM) FUSION DEVICE
K111119 · ODP
Zimmer Spine, Inc.
Orthopedic · 216d
Cleared Nov 23, 2011
PROFEMUR GLADIATOR HA HIP STEM
K112150 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 119d
Cleared Nov 22, 2011
DEVINE SPINAL SYSTEM
K111690 · MNH
Changzhou Orthmed Medical Instrument...
Orthopedic · 159d
Cleared Nov 22, 2011
NB3D BONE VOID FILLER
K111944 · MQV
Pioneer Surgical Technology, Inc.
Orthopedic · 137d
Cleared Nov 22, 2011
ZAVATION SPINAL SYSTEM
K112484 · MNI
Zavation, LLC
Orthopedic · 85d