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
11761–11784 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 15, 2003
KYPHX DIRECTIONAL INFLATABLE BONE TAMP, MODELS K16A AND K17A
K032212 · HRX
Kyphon, Inc.
Orthopedic · 56d
Cleared Sep 12, 2003
CD HORIZON SPINAL SYSTEM
K032033 · NKB
Medtronic Sofamor Danek
Orthopedic · 73d
Cleared Sep 12, 2003
DURACON TOTAL KNEE SYSTEM
K032163 · MBH
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Sep 12, 2003
MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
K032588 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 21d
Cleared Sep 11, 2003
SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM
K031985 · MNI
Spinal Concepts, Inc.
Orthopedic · 76d
Cleared Sep 11, 2003
DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K032418 · MBH
Howmedica Osteonics Corp.
Orthopedic · 37d
Cleared Sep 10, 2003
IP-XS COMPRESSION NAIL SYSTEM
K032548 · HSB
Plus Orthopedics
Orthopedic · 23d
Cleared Sep 05, 2003
TI FENESTRATED PLATE
K031772 · KWP
Interpore Cross Intl.
Orthopedic · 88d
Cleared Sep 05, 2003
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
K031973 · LXT
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 05, 2003
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · KWT
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 04, 2003
EBI XFIX DFS SYSTEM
K031919 · KTT
Ebi, L.P.
Orthopedic · 73d
Cleared Sep 04, 2003
ALANTECH GRAFT FIXATION SCREW
K031937 · HWC
Arthrocare Corp.
Orthopedic · 73d
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032 · HRS
Synthes (Usa)
Orthopedic · 65d
Cleared Sep 04, 2003
CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE)
K032037 · MNI
Medtronic Sofamor Danek
Orthopedic · 65d
Cleared Sep 04, 2003
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
K032479 · JWH
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Sep 03, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031833 · MNI
Medtronic Sofamor Danek
Orthopedic · 82d
Cleared Sep 02, 2003
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
K031729 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Aug 29, 2003
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM
K024313 · MNI
Pisharodi Surgicals, Inc.
Orthopedic · 248d
Cleared Aug 29, 2003
KAPP CUSTOM RADIAL HEAD ELBOW IMPLANT
K030237 · KWI
Kapp Surgical Instrument, Inc.
Orthopedic · 218d
Cleared Aug 29, 2003
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K031730 · JDI
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 29, 2003
VITOSS SCAFFOLD SYNTHETIC CANCELLOUS BONE VOID FILLER
K032409 · MQV
Orthovita, Inc.
Orthopedic · 25d
Cleared Aug 29, 2003
S2 NAIL SYSTEM
K032579 · HSB
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
K031712 · HTY
Inion , Ltd.
Orthopedic · 87d
Cleared Aug 25, 2003
MITEK MICRO QUICKANCHOR
K032078 · NOV
Mitek Worldwide
Orthopedic · 49d