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
8305–8328 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 02, 2011
LAGUNA PEDICLE SCREW SYSTEM
K103748 · NKB
Phygen, LLC
Orthopedic · 69d
Cleared Mar 01, 2011
MSA HIP SYSTEM
K102172 · MEH
Global Manufacturing Technology
Orthopedic · 211d
Cleared Feb 28, 2011
KYPHON XPEDE BONE CEMENT
K102397 · NDN
Medtronic
Orthopedic · 188d
Cleared Feb 28, 2011
CORIN BIOLOX DELTA FEMORAL HEADS
K103120 · LZO
Corin USA
Orthopedic · 129d
Cleared Feb 28, 2011
LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K103660 · ODP
Lanx, Inc.
Orthopedic · 75d
Cleared Feb 28, 2011
VERTICOR K-WIRE SYSTEM
K110047 · HTY
Verticor, Ltd.
Orthopedic · 53d
Cleared Feb 28, 2011
VANGUARD ASYMMETRICAL PATELLAR COMPONENT
K110362 · JWH
Biomet Manufacturing Corp
Orthopedic · 20d
Cleared Feb 24, 2011
ICUFF REPAIR PLATE, RIGHT
K102539 · MBI
Shoulder Options, Inc.
Orthopedic · 174d
Cleared Feb 24, 2011
PICCOLO COMPOSITE PLATE SYSTEM
K102597 · HRS
N.M.B. Medical Applications, Ltd.
Orthopedic · 167d
Cleared Feb 23, 2011
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
K102125 · JWH
Biomet, Inc.
Orthopedic · 209d
Cleared Feb 17, 2011
ROCKWOOD CLAVICLE PINS
K103001 · JDW
DePuy Orthopaedics, Inc.
Orthopedic · 134d
Cleared Feb 17, 2011
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
K103383 · NKB
Spartek Medical, Inc.
Orthopedic · 91d
Cleared Feb 17, 2011
EXPEDIUM SPINE SYSTEM, MOSS MIAMI SPINE SYSTEM
K103490 · NKB
Johnson & Johnson
Orthopedic · 83d
Cleared Feb 16, 2011
ARTHROCARE PARALLAX CONTOUR VERTEBRAL AUGMENTATION DEVICE
K110183 · NDN
Arthrocare Corp.
Orthopedic · 26d
Cleared Feb 15, 2011
SURGICRAFT LOCKDOWN ACROMIOCLAVICULAR (AC) DEVICE
K091207 · HTN
Surgicraft , Ltd.
Orthopedic · 662d
Cleared Feb 15, 2011
TRABECULAR METAL FEMORAL CONE AUGMENTS
K103517 · MBH
Zimmer Trabecular Metal Technology, Inc.
Orthopedic · 77d
Cleared Feb 15, 2011
PSL ANTERIOR CERVICAL PLATE SYSTEM
K103819 · KWQ
Precision Surgery , Ltd.
Orthopedic · 47d
Cleared Feb 15, 2011
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
K103838 · KWQ
Precision Surgery , Ltd.
Orthopedic · 47d
Cleared Feb 15, 2011
AXSOS LOCKED PLATING 4.0MM LOCKING INSERTS
K110176 · HRS
Howmedica Osteonics Corp., Dba...
Orthopedic · 25d
Cleared Feb 14, 2011
SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
K103491 · KWQ
A Johnson & Johnson Company
Orthopedic · 80d
Cleared Feb 11, 2011
4CIS VANE SPINE SYSTEM
K101818 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 226d
Cleared Feb 11, 2011
BRIGHT SPINE GALILEO SPINAL SPACER SYSTEM
K102449 · ODP
Bright Spine, Inc.
Orthopedic · 168d
Cleared Feb 11, 2011
VERSAFITCUP CC TRIO
K103352 · LZO
Medacta International
Orthopedic · 87d
Cleared Feb 10, 2011
LANX FUSION SYSTEM
K102738 · OVD
Lanx, LLC
Orthopedic · 141d