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
6913–6936 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 03, 2013
SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
K132366 · KWQ
Accel Spine
Orthopedic · 35d
Cleared Sep 03, 2013
U-MOTION II PS+ CUP
K132455 · LZO
United Orthopedic Corp.
Orthopedic · 28d
Cleared Aug 30, 2013
SIRIUS FEMORAL STEM
K130610 · JDI
Biomet, Inc.
Orthopedic · 176d
Cleared Aug 30, 2013
RANGE SPINAL SYSTEM
K131784 · OSH
K2m, Inc.
Orthopedic · 73d
Cleared Aug 30, 2013
UTF STEM-REDUCED, ADDITIONAL SIZES
K132207 · LPH
United Orthopedic Corporation
Orthopedic · 45d
Cleared Aug 29, 2013
NUVASIVE DECADE LATERAL PLATE SYSTEM
K130868 · KWQ
Nuvasive, Inc.
Orthopedic · 153d
Cleared Aug 29, 2013
ASPIRON ACP SYSTEM
K131200 · KWQ
U&I Corporation
Orthopedic · 122d
Cleared Aug 29, 2013
ROTATION MEDICAL BONE STAPLE (RMB STAPLE)
K131635 · MBI
Rotation Medical, Inc.
Orthopedic · 86d
Cleared Aug 29, 2013
TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR...
K132012 · KWQ
Zimmer Spine, Inc.
Orthopedic · 59d
Cleared Aug 28, 2013
STALIF X
K130461 · OVD
Centinel Spine, Inc.
Orthopedic · 187d
Cleared Aug 28, 2013
BIORETEC ACTIVASCREW INTERFERENCE
K130716 · MAI
Bioretec, Ltd.
Orthopedic · 166d
Cleared Aug 28, 2013
RESTORE BUNION CORRECTION SYSTEM
K131061 · JDR
Nextremity Solutions
Orthopedic · 134d
Cleared Aug 28, 2013
SEVIIN FRACTURE SHOULDER
K131277 · KWS
Ingen Orthopedics, LLC
Orthopedic · 114d
Cleared Aug 28, 2013
SELF-COMPRESSIVE SCREW
K131471 · HWC
Neosteo
Orthopedic · 98d
Cleared Aug 26, 2013
SEVIIN SURFACE REPLACEMENT SHOULDER
K130635 · HSD
Ingen Orthopedics, LLC
Orthopedic · 168d
Cleared Aug 26, 2013
INTERFORM INTERBODY CAGE SYSTEM
K131082 · MAX
Next Orthosurgical
Orthopedic · 130d
Cleared Aug 23, 2013
TEMPUS(TM) CERVICAL PLATE SYSTEM
K131374 · KWQ
Neurostructures, LLC
Orthopedic · 102d
Cleared Aug 23, 2013
LLIAD, KORA, ZENIUS PEDICLE SCREW SYSTEM
K131878 · NKB
Medyssey USA, Inc.
Orthopedic · 60d
Cleared Aug 22, 2013
GMK FULL PE TIBIAL COMPONENTS
K131310 · JWH
Medacta International
Orthopedic · 107d
Cleared Aug 22, 2013
FLOWER SMALL AND MEDIUM IMPLANT SET
K131657 · HRS
Flower Orthopedics Corporation
Orthopedic · 77d
Cleared Aug 22, 2013
AVENIR CEMENTED HIP STEM
K131884 · LZO
Zimmer GmbH
Orthopedic · 58d
Cleared Aug 22, 2013
MOUNTAINEER OCT SPINAL SYSTEM
K132332 · KWP
Medos International SARL
Orthopedic · 27d
Cleared Aug 21, 2013
SWING-OFF SCREW
K130627 · HWC
Advanced Interventional Technology, LLC
Orthopedic · 166d
Cleared Aug 20, 2013
STAXX IBL SYSTEM
K131071 · MAX
Spine Wave, Inc.
Orthopedic · 125d