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
7537–7560 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 20, 2012
DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE
K121835 · JWH
Encore Medical, L.P.
Orthopedic · 28d
Cleared Jul 19, 2012
SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING
K120211 · LZO
Smith & Nephew, Inc.
Orthopedic · 177d
Cleared Jul 18, 2012
3.9MM REELX STT SUTURE ANCHOR SYSTEM
K120824 · MBI
Stryker Corp.
Orthopedic · 121d
Cleared Jul 18, 2012
M.U.S.T PEDICLE SCREW SYSTEM
K121115 · KWP
Medacta International
Orthopedic · 97d
Cleared Jul 18, 2012
MEDICREA INTERNATIONAL ANTERIOR LUMBAR PLATE
K121323 · KWQ
Medicrea International
Orthopedic · 77d
Cleared Jul 18, 2012
IO FIX, IO FIX PLUS, CARPALFIX, EXTREMITY MEDICAL SCREW AND WASHER
K121349 · HWC
Extremity Medical, LLC
Orthopedic · 75d
Cleared Jul 18, 2012
XMCP, HALLUX, TARSX, EXTREMITY MEDICAL SCREW SYSTEM
K121417 · HWC
Extremity Medical, LLC
Orthopedic · 68d
Cleared Jul 18, 2012
PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM
K121671 · NKB
Zimmer Spine, Inc.
Orthopedic · 42d
Cleared Jul 18, 2012
U2 ACETABULAR CUP, PLASMA SPRAY
K121777 · LPH
United Orthopedic Corp.
Orthopedic · 30d
Cleared Jul 16, 2012
CALYPSO SYSTEM
K120564 · NKB
Hogan Lovells US LLP
Orthopedic · 143d
Cleared Jul 16, 2012
NUVASIVE BRIGADE ANTERIOR PLATE SYSTEM
K121837 · KWQ
Nuvasive, Inc.
Orthopedic · 24d
Cleared Jul 13, 2012
CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE
K120903 · HRS
Acumed, LLC
Orthopedic · 109d
Cleared Jul 13, 2012
INFILL INTERVERTEBRAL BODY FUSION DEVICE
K121733 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 30d
Cleared Jul 12, 2012
ARROW REVERSE SHOULDER SYSTEM
K112193 · PHX
Fournitures Hospitalieres Industrie
Orthopedic · 349d
Cleared Jul 11, 2012
SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM
K112748 · KWQ
Spinal USA, LLC
Orthopedic · 294d
Cleared Jul 09, 2012
SEVIIN REVERSE SHOULDER
K120374 · PHX
Ingen Orthopedics, LLC
Orthopedic · 154d
Cleared Jul 06, 2012
SYNTHES MULTILOC HUMERAL NAILING SYSTEM
K120807 · HSB
Synthes USA Products, LLC
Orthopedic · 112d
Cleared Jul 06, 2012
VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K121096 · MAX
L & K Biomed Co., Ltd.
Orthopedic · 86d
Cleared Jul 06, 2012
SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL...
K121601 · HRS
Synthes (Usa)
Orthopedic · 35d
Cleared Jul 05, 2012
AEQUALIS ADJUSTABLE MODULAR REVERSE SHOULDER SYSTEM
K120739 · PHX
Tornier, Inc.
Orthopedic · 115d
Cleared Jul 05, 2012
CD HORIZON SPINAL SYSTEM
K121680 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Jul 05, 2012
ACCULIF TL CAGE
K121683 · MAX
Coalign Innovations, Inc.
Orthopedic · 28d
Cleared Jul 03, 2012
SPINAL ELEMENTS CERCLAGE SYSTEM
K120177 · JDQ
Spinal Elements, Inc.
Orthopedic · 165d
Cleared Jul 03, 2012
DEPUY PULSE LUMBAR CAGE SYSTEM
K120966 · MAX
Medos International SARL
Orthopedic · 95d