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
8161–8184 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 15, 2011
BIOSPINE VBR SYSTEM
K110864 · MQP
Aesculap Implant Systems, LLC
Orthopedic · 78d
Cleared Jun 14, 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · PHX
Tornier, Inc.
Orthopedic · 104d
Cleared Jun 13, 2011
4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM
K102458 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 290d
Cleared Jun 13, 2011
MECTALIF
K110927 · MAX
Medacta International
Orthopedic · 77d
Cleared Jun 13, 2011
SPINEOLOGY PEEK LUMBAR INTERBODY FUSION DEVICE
K110933 · MAX
Spineology, Inc.
Orthopedic · 70d
Cleared Jun 10, 2011
EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)
K111471 · MBI
Medshape Solutions, Inc.
Orthopedic · 14d
Cleared Jun 08, 2011
TSRH SPINAL SYSTEM
K110070 · NKB
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 149d
Cleared Jun 08, 2011
NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM
K110284 · MNI
Medyssey Co, Ltd.
Orthopedic · 127d
Cleared Jun 08, 2011
EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE...
K111379 · KWS
Exactech, Inc.
Orthopedic · 22d
Cleared Jun 06, 2011
MINI VARIABLE SYSTEM
K111041 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 53d
Cleared Jun 02, 2011
BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM
K103205 · KWP
Alphatec Spine, Inc.
Orthopedic · 213d
Cleared Jun 02, 2011
APTUS CANNULATED COMPRESSION SCREWS
K110658 · HWC
Medartis AG
Orthopedic · 87d
Cleared Jun 02, 2011
TORNIER INSITE FT SUTURE ANCHOR
K110773 · MBI
Tornier, Inc.
Orthopedic · 73d
Cleared Jun 01, 2011
MIS ANTERIOR CERVICAL PLATING SYSTEM
K103423 · KWQ
Life Spine
Orthopedic · 191d
Cleared May 27, 2011
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K110226 · MAX
Vertebral Technologies, Inc.
Orthopedic · 122d
Cleared May 27, 2011
5.5 / 6.5MM SPARTAN PEEK SURTURE IMPLANT WITH #2 MAGNUMWIRE / WITH NEEDLES,...
K110781 · MBI
Arthrocare Corp.
Orthopedic · 67d
Cleared May 27, 2011
GMK REVISION HYBRID LINERS
K111283 · JWH
Medacta International
Orthopedic · 21d
Cleared May 25, 2011
TIGER SPINE SYSTEM
K110321 · MNH
Corelink, LLC
Orthopedic · 111d
Cleared May 25, 2011
NANOTACK SUTURE ANCHOR 1.4MM
K110473 · MBI
Pivot Medical
Orthopedic · 96d
Cleared May 25, 2011
LEUCADIA PEDICLE SCREW SYSTEM
K110588 · NKB
Phygen, LLC
Orthopedic · 84d
Cleared May 25, 2011
ABG II MONOLITHIC HIP STEM
K110807 · MAY
Stryker Corp.
Orthopedic · 63d
Cleared May 24, 2011
TOTAL SHOULDER SYSTEM
K110905 · KWS
Shoulder Innovations, LLC
Orthopedic · 54d
Cleared May 24, 2011
ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME...
K111183 · KWP
Orthofix, Inc.
Orthopedic · 27d
Cleared May 24, 2011
SYNTHES 3.5MM LOW PROFILE CORTICAL SCREW
K111230 · HWC
Synthes USA Products, LLC
Orthopedic · 22d