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
8857–8880 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 23, 2009
PATRIOT TRANSCONTINENTAL LLIF SPACER
K093242 · MAX
Globus Medical, Inc.
Orthopedic · 69d
Cleared Dec 23, 2009
INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076
K093675 · MAX
Vertebral Technologies, Inc.
Orthopedic · 26d
Cleared Dec 23, 2009
AVS PL PEEK SPACERS
K093704 · MAX
Stryker Corp.
Orthopedic · 22d
Cleared Dec 22, 2009
CHOICE SPINE ANTERIOR CERVICAL PLATE (ACP) SYSTEM
K091926 · KWQ
Choicespine, LP
Orthopedic · 175d
Cleared Dec 22, 2009
PATHWAY IVB/VBR
K092904 · ODP
Custom Spine, Inc.
Orthopedic · 92d
Cleared Dec 21, 2009
VERTECEM
K090435 · NDN
Teknimed, S.A.
Orthopedic · 305d
Cleared Dec 21, 2009
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS
K091543 · MBH
Smith & Nephew, Inc.
Orthopedic · 209d
Cleared Dec 18, 2009
RESTORATION ADM SYSTEM X3 ACETABULAR
K093644 · MEH
Howmedica Osteonics Corp.
Orthopedic · 23d
Cleared Dec 17, 2009
SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR
K093428 · MBI
Smith & Nephew Endoscopy, Inc.
Orthopedic · 44d
Cleared Dec 17, 2009
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
K093646 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 22d
Cleared Dec 16, 2009
FOOT AND HAND MOTION SYSTEM
K091118 · HWC
Newclip Technics
Orthopedic · 243d
Cleared Dec 16, 2009
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
K093513 · NPJ
Conformis, Inc.
Orthopedic · 33d
Cleared Dec 16, 2009
MODIFICATION TO CASPIAN SPINAL SYSTEM
K093534 · KWP
K2m, Inc.
Orthopedic · 30d
Cleared Dec 16, 2009
44MM E1 ACETABULAR LINER WITH 44MM BIOLOX DELTA OPTION CERAMIC HEAD OR 44MM M...
K093549 · LZO
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Dec 15, 2009
LIFE SPINE STAND-ALONE SPACER SYSTEM
K091301 · OVD
Life Spine
Orthopedic · 225d
Cleared Dec 15, 2009
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K092325 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 133d
Cleared Dec 15, 2009
EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS
K092548 · KYI
Extremity Medical, LLC
Orthopedic · 118d
Cleared Dec 15, 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · NPJ
Smith & Nephew, Inc.
Orthopedic · 76d
Cleared Dec 15, 2009
INTEGRA TOTAL WRIST FUSION SYSTEM
K093163 · HRS
Integra LifeSciences Corporation
Orthopedic · 70d
Cleared Dec 15, 2009
SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR
K093228 · MBI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Dec 10, 2009
AFGHAN EXTERNAL FIXATOR
K092002 · KTT
Smith & Nephew, Inc.
Orthopedic · 161d
Cleared Dec 10, 2009
MODIFICATION TO LANX SPINAL FIXATION SYSTEM
K093285 · MNI
Lanx, LLC
Orthopedic · 51d
Cleared Dec 09, 2009
EIDOSMED, MODEL EDG4.0
K091992 · OOL
Eidosmed, LLC
Orthopedic · 160d
Cleared Dec 09, 2009
WEDGELOC 180X (STANDARD) AND (CORTICAL) SUTURE ANCHOR WITH OPTI-FIBER SUTURES
K092914 · MBI
Medshape Solutions
Orthopedic · 78d