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
7825–7848 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 11, 2012
SUSPENSION CLAVICLE FRACTURE REPAIR SYSTEM
K113405 · HRS
Suspension Orthopaedic Solutions, LLC
Orthopedic · 54d
Cleared Jan 10, 2012
ALEUTIAN SYSTEM
K113138 · MAX
K2m, Inc.
Orthopedic · 77d
Cleared Jan 10, 2012
DSS STABILIZATION SYSTEM
K113625 · NKB
Paradigm Spine, LLC
Orthopedic · 33d
Cleared Jan 09, 2012
LABRALINK SUTURE ANCHOR WITH INSERTER, 2.9MM PER-LOADED WITH ONE (1) AND (2)...
K112960 · MBI
Cayenne Medical, Inc.
Orthopedic · 96d
Cleared Jan 06, 2012
APTUS WRIST ARTHRODESIS PLATES
K112169 · HRS
Medartis AG
Orthopedic · 162d
Cleared Jan 06, 2012
ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER
K112301 · HSX
Materialise NV
Orthopedic · 149d
Cleared Jan 06, 2012
IVAS 20MM (10 GAUGE) BALLOON CATHETER
K113477 · NDN
Stryker Instruments, Instruments Div.
Orthopedic · 44d
Cleared Jan 05, 2012
PROMOS MODULAR SHOULDER SYSTEM
K113012 · KWS
Smith & Nephew, Inc.
Orthopedic · 86d
Cleared Jan 05, 2012
SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM...
K113038 · HSX
Smith & Nephew, Inc.
Orthopedic · 85d
Cleared Jan 05, 2012
APEX ARC HIP STEM
K113242 · LPH
Omni Life Science, Inc.
Orthopedic · 64d
Cleared Jan 04, 2012
DYNA LOCKING CANNULATED SCREW
K112240 · HWC
U&I Corp.
Orthopedic · 153d
Cleared Jan 04, 2012
FOCUS MIS SYSTEM
K112643 · NKB
L & K Biomed Co., Ltd.
Orthopedic · 114d
Cleared Jan 04, 2012
DNE EXTERNAL FIXATION SYSTEM
K113106 · KTT
Dne, LLC
Orthopedic · 76d
Cleared Jan 04, 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · LPH
Exactech, Inc.
Orthopedic · 29d
Cleared Dec 30, 2011
STABLYX CMC ARTHROPLASTY IMPLANT MODEL SIZES 1, 2, 3, 4, AND 5
K111068 · KYI
Skeletal Dynamics, LLC
Orthopedic · 256d
Cleared Dec 29, 2011
LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
K113559 · ODP
Ldr Spine USA, Inc.
Orthopedic · 28d
Cleared Dec 28, 2011
ARTS2 SPINAL FIXATION SYSTEM
K103573 · MNH
Advanced Medical Technologies
Orthopedic · 387d
Cleared Dec 28, 2011
PRESERVE HIP STEM
K112080 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 160d
Cleared Dec 27, 2011
SUSPENSION CLAVICLE FRACTURE FIXATION SYSTEM
K112923 · HRS
Suspension Orthopaedic Solutions, LLC
Orthopedic · 85d
Cleared Dec 23, 2011
ZAVATION IBF SYSTEMS
K112664 · ODP
Zavation, LLC
Orthopedic · 101d
Cleared Dec 23, 2011
STRYKER RESORBABLE FIXATION SYSTEM
K113109 · HRS
Stryker
Orthopedic · 64d
Cleared Dec 22, 2011
CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G
K112907 · NDN
Medos International SARL
Orthopedic · 80d
Cleared Dec 22, 2011
COLS PEEK
K113591 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 17d
Cleared Dec 21, 2011
ARTHREX FRACTURE SYSTEM
K112437 · HTN
Arthrex, Inc.
Orthopedic · 119d