FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
13537–13560 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 04, 1999
POLYMER OBL SB ANCHOR / SUTURE COMBINATION
K982996 · JDR
Orthopaedic Biosystems, Ltd.
Orthopedic · 189d
Cleared Mar 04, 1999
TRANSFX EXTERNAL FIXATION SYSTEM
K984357 · LXT
Immedica, Inc.
Orthopedic · 87d
Cleared Mar 02, 1999
SYNTEC-TAICHUNG NON-STERILE SMALL ORTHOPEDIC FIXATION SYSTEM, MODEL 71100,...
K984364 · KTT
Syntec Scientific Corp.
Orthopedic · 85d
Cleared Mar 02, 1999
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
K990131 · MQV
Interpore Cross Intl.
Orthopedic · 47d
Cleared Mar 01, 1999
SUTURELESS ANCHOR
K984490 · MAI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Mar 01, 1999
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM,...
K984543 · HSB
Syntec Scientific Corp.
Orthopedic · 70d
Cleared Mar 01, 1999
ANATOMICA GLENOID COMPONENT
K990136 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 46d
Cleared Feb 26, 1999
STIMULAN- CALCIUM SULFATE BONE VOID FILLER
K982663 · MQV
Encore Orthopedics, Inc.
Orthopedic · 211d
Cleared Feb 26, 1999
ARTHRO-SURGIMAT-2000 ECU
K990443 · HRX
W.O.M. World of Medicine GmbH
Orthopedic · 15d
Cleared Feb 24, 1999
FLEXPOSURE RETRACTOR
K983144 · HRX
Endius, Inc.
Orthopedic · 169d
Cleared Feb 24, 1999
ECHELON HIP STEM
K983834 · LPH
Smith & Nephew, Inc.
Orthopedic · 117d
Cleared Feb 24, 1999
XIA SPINE SYSTEM
K984251 · KWQ
Howmedica, Inc.
Orthopedic · 89d
Cleared Feb 24, 1999
DALL-MILES CABLE GRIP (A-GRIP)
K984432 · JDQ
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 24, 1999
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K984585 · KWL
Osteonics Corp.
Orthopedic · 62d
Cleared Feb 24, 1999
J-SERIES OMEGA TOTAL HIP SYSTEM
K990003 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 51d
Cleared Feb 18, 1999
LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT
K984296 · LPH
Biomet, Inc.
Orthopedic · 79d
Cleared Feb 18, 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498 · KTT
Synthes (Usa)
Orthopedic · 63d
Cleared Feb 18, 1999
MODULAR PROTUSIO CUP
K990032 · JDI
Biomet, Inc.
Orthopedic · 43d
Cleared Feb 18, 1999
KMI WRIST FUSION SYSTEM
K990094 · HRS
Kinetikos Medical, Inc.
Orthopedic · 37d
Cleared Feb 18, 1999
ANATOMICA HUMERAL STEM/HEAD COMPONENTS
K990137 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 35d
Cleared Feb 18, 1999
OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS
K990203 · MEH
Osteonics Corp.
Orthopedic · 28d
Cleared Feb 16, 1999
MICROTAC-BONE ANCHOR SYSTEM
K990160 · MBI
Influence, Inc.
Orthopedic · 28d
Cleared Feb 12, 1999
130 MODIFIED INTEGRAL FEMORAL COMPONENT
K984408 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Feb 12, 1999
AGEE-WRISTJACK FRACTURE REACTION SYSTEM (STERILE VERSION), MODEL CFD-147
K984442 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 60d