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
9385–9408 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 16, 2008
NCB POLYAXIAL LOCKING PLATE SYSTEM, PROXIMAL HUMERAL PLATES, ZIMMER UNIVERSAL...
K081759 · HRS
Zimmer GmbH
Orthopedic · 118d
Cleared Oct 16, 2008
POLYBONE GRANULE & BLOCK
K082338 · MQV
Kyung Won Medical Co., Ltd.
Orthopedic · 63d
Cleared Oct 16, 2008
GRAFTON R II EDBM, DEMINERALIZED BONE MATRIX ALLOGRAFT, RESORBABLE CALCIUM...
K082615 · MQV
Osteotech, Inc.
Orthopedic · 37d
Cleared Oct 16, 2008
MODIFICATION TO: CAPSTONE SPINAL SYSTEM
K082732 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 28d
Cleared Oct 15, 2008
MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III
K082081 · HSX
Mako Surgical Corp.
Orthopedic · 84d
Cleared Oct 15, 2008
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS
K082398 · LZO
Encore Medical, L.P.
Orthopedic · 56d
Cleared Oct 15, 2008
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS
K082446 · KWA
Biomet, Inc.
Orthopedic · 51d
Cleared Oct 10, 2008
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE
K080399 · MBP
Musculoskeletal Transplant Foundation
Orthopedic · 239d
Cleared Oct 10, 2008
CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS
K081107 · KWP
K2m, Inc.
Orthopedic · 175d
Cleared Oct 10, 2008
TRICOS A RESORBABLE BONE SUBSTITUTE
K081717 · MQV
Baxter Healthcare Corp
Orthopedic · 114d
Cleared Oct 10, 2008
ENSPLINTCMX CLAVICLE PIN
K081832 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 105d
Cleared Oct 10, 2008
STARR FRAME STEINMANN PIN
K082017 · HTY
Starr Frame, LLC
Orthopedic · 86d
Cleared Oct 10, 2008
T2 FLEXIBLE NAIL
K082018 · HSB
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Oct 10, 2008
CD HORIZON SPINAL SYSTEM
K082236 · NKB
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Oct 10, 2008
NUVASIVE SPHERX SYSTEM
K082332 · NKB
Nuvasive, Inc.
Orthopedic · 57d
Cleared Oct 10, 2008
EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY
K082702 · PHX
Exactech, Inc.
Orthopedic · 24d
Cleared Oct 08, 2008
LDR SPINE EASYSPINE SYSTEM
K082592 · NKB
Ldr Spine USA
Orthopedic · 30d
Cleared Oct 07, 2008
SYNERGY SPINAL SYSTEM (6.35 POLARIS)
K081952 · NKB
Biomet Spine
Orthopedic · 90d
Cleared Oct 07, 2008
MODIFICATION TO MICROFUSE BONE VOID FILLER
K082442 · MQV
Globus Medical, Inc.
Orthopedic · 43d
Cleared Oct 07, 2008
RADIUS SPINAL SYSTEM, VITALLIUM ROD #486613601
K082608 · NKB
Stryker Spine
Orthopedic · 29d
Cleared Oct 06, 2008
SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS...
K082032 · NKB
Abbott Spine, Inc.
Orthopedic · 81d
Cleared Oct 03, 2008
PASS 2 SPINAL SYSTEM
K082069 · MNI
Medicrea Technologies
Orthopedic · 73d
Cleared Oct 03, 2008
STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION
K082567 · HRY
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 03, 2008
PASS LP SPINAL SYSTEM
K082577 · MNH
Medicrea Technologies
Orthopedic · 28d