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
8089–8112 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 02, 2011
UNITED U2 XPE TOTAL KNEE SYSTEM
K103733 · JWH
United Orthopedic Corporation
Orthopedic · 223d
Cleared Aug 02, 2011
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
K110679 · NKB
Phygen, LLC
Orthopedic · 145d
Cleared Aug 02, 2011
MESA SPINAL SYSTEM (KEYSTONE RODS)
K110991 · MNI
K2m, Inc.
Orthopedic · 116d
Cleared Aug 02, 2011
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
K111253 · HRS
Arthrex, Inc.
Orthopedic · 90d
Cleared Aug 02, 2011
VU C*POD INTERVERTEBRAL BODY FUSION DEVICE
K111675 · ODP
Theken Spine, LLC
Orthopedic · 48d
Cleared Jul 28, 2011
N-FORCE FIXATION SYSTEM
K102528 · HWC
Innovision, Inc.
Orthopedic · 328d
Cleared Jul 28, 2011
SYNTHES STERNAL ZIPFIX SYSTEM
K110789 · JDQ
Synthes (Usa)
Orthopedic · 128d
Cleared Jul 28, 2011
PARCUS 2.0MM / 2.5MM / 3.5MM MITI TITANIUM SUTURE ANCHOR
K111000 · HWC
Parcus Medical, LLC
Orthopedic · 108d
Cleared Jul 28, 2011
SMR SHOULDER SYSTEM- REVISION STEMS
K111212 · KWS
Lima Corporate S.P.A.
Orthopedic · 90d
Cleared Jul 28, 2011
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
K111400 · JWH
Exactech, Inc.
Orthopedic · 70d
Cleared Jul 26, 2011
APEX SPINE SYSTEM
K110906 · NKB
Spinecraft, LLC
Orthopedic · 117d
Cleared Jul 25, 2011
3.7MM/5.0MM DYNAMIC LOCKING SCREW
K110592 · HWC
Synthes (Usa)
Orthopedic · 145d
Cleared Jul 25, 2011
GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM
K110990 · KWQ
Gold Standard Orthopedics, LLC
Orthopedic · 108d
Cleared Jul 22, 2011
VENUS CERVICAL SPINAL FIXATION SYSTEM
K103414 · MNI
L & K Biomed Co., Ltd.
Orthopedic · 242d
Cleared Jul 22, 2011
MAESTRO WRIST PLATING SYSTEM
K110271 · HRS
Biomet Manufacturing Corp
Orthopedic · 172d
Cleared Jul 22, 2011
CERVICAL CAGE
K110915 · ODP
Eisertech, LLC
Orthopedic · 112d
Cleared Jul 22, 2011
GIL ANCHOR / GIL QUICK ANCHOR PLUS, HEALIX TI DUAL THREADED SUTURE ANCHOR,...
K111631 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 39d
Cleared Jul 22, 2011
NUVASIVE ANTERIOR LUMBAR PLATE SYSTEM
K111866 · KWQ
Nuvasive, Inc.
Orthopedic · 22d
Cleared Jul 21, 2011
ETURN SPINAL IMPLANT MODEL ETURN XX-12
K100305 · MAX
Icotec
Orthopedic · 533d
Cleared Jul 21, 2011
DSC/ALF SPINAL SYSTEM
K101886 · MQP
Sintea Plastek, LLC
Orthopedic · 380d
Cleared Jul 21, 2011
COREN TOTAL HIP SYSTEM
K103431 · LPH
Corentec Co., Ltd.
Orthopedic · 240d
Cleared Jul 21, 2011
GENESYS SPINE TILOCK SYSTEM
K103671 · NKB
Genesys Spine
Orthopedic · 217d
Cleared Jul 21, 2011
DEPUY MITEK MILAGRO INTERFERENCE SCREW MODEL 231803, 231804, 231807, 231809
K103831 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 203d
Cleared Jul 21, 2011
EXPLOR RADIAL HEAD PLATING SYSTEM
K110201 · HRS
Biomet, Inc.
Orthopedic · 178d