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
6337–6360 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 30, 2014
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
K132912 · HWC
In2bones Sas
Orthopedic · 316d
Cleared Jul 30, 2014
K2M MODULAR HOOKS
K133402 · NKB
K2m, Inc.
Orthopedic · 266d
Cleared Jul 30, 2014
OPTETRAK LOGIC POROUS FEMORAL COMPONENTS
K140302 · MBH
Exactech, Inc.
Orthopedic · 174d
Cleared Jul 30, 2014
VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT
K140883 · MBH
Biomet, Inc.
Orthopedic · 114d
Cleared Jul 30, 2014
ALPINE HIP STEM
K141001 · LPH
Ortho Development
Orthopedic · 103d
Cleared Jul 30, 2014
G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
K141011 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 103d
Cleared Jul 29, 2014
Kangli Locking Plate System
K133840 · HRS
Suzhou Kangli Orthopaedics Instrument...
Orthopedic · 223d
Cleared Jul 29, 2014
IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
K133947 · OVD
X-Spine Systems, Inc.
Orthopedic · 218d
Cleared Jul 29, 2014
PEDILOC FRAGMENT SYSTEM
K140431 · HRS
OrthoPediatrics Corp.
Orthopedic · 159d
Cleared Jul 29, 2014
CAMERA ENABLED PROBE
K141119 · HRX
Trice Medical, Inc.
Orthopedic · 90d
Cleared Jul 29, 2014
ALTEON 6.5MM BONE SCREWS
K141797 · LPH
Exactech, Inc.
Orthopedic · 27d
Cleared Jul 28, 2014
HUMELOCK II CEMENTED SHOULDER SYSTEM
K140071 · KWT
Fx Solutions
Orthopedic · 196d
Cleared Jul 28, 2014
COROENT XL-F SYSTEM
K140479 · OVD
Nu Vasive, Incorporated
Orthopedic · 152d
Cleared Jul 28, 2014
COROENT SMALL INTERBODY SYSTEM
K140921 · ODP
Nu Vasive, Incorporated
Orthopedic · 109d
Cleared Jul 25, 2014
MLX - MEDIAL LATERAL EXPANDABLE LUMBAR INTERBODY SYSTEM
K140770 · MAX
Nu Vasive, Incorporated
Orthopedic · 120d
Cleared Jul 24, 2014
PLIF LITE AND TLIF LITE
K132907 · MAX
Sintea Plustek
Orthopedic · 310d
Cleared Jul 24, 2014
C-JAWS CERVICAL COMPRESSIVE STAPLE
K133906 · PHQ
Medicrea International
Orthopedic · 213d
Cleared Jul 24, 2014
LINOS MOH HAND PLATING SYSTEM
K141489 · HRS
KLS-Martin L.P.
Orthopedic · 49d
Cleared Jul 24, 2014
PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE...
K141711 · MBI
Pontis Orthopaeeics, LLC
Orthopedic · 29d
Cleared Jul 23, 2014
VILEX ULTIMA EXTERNAL FIXATION SYSTEM WITH HA COATED PINS AND WIRES
K132820 · JDW
Vilex, Inc.
Orthopedic · 317d
Cleared Jul 23, 2014
INTELLIJOINT HIP
K133759 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 224d
Cleared Jul 23, 2014
IFUSE IMPLANT SYSTEM
K141049 · OUR
SI-BONE, Inc.
Orthopedic · 91d
Cleared Jul 23, 2014
CASPIAN SPINAL SYSTEM
K141284 · KWP
K2m, Inc.
Orthopedic · 68d
Cleared Jul 23, 2014
ORTHO SOLUTIONS ULTOS PLATING SYSTEM
K141784 · HRS
Ortho Solutions Limited
Orthopedic · 21d