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
13201–13224 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 13, 2000
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K994207 · KRO
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 10, 2000
SPIRAL RADIUS RODDING SYSTEM
K000009 · KWQ
United States Surgical, A Division of...
Orthopedic · 67d
Cleared Mar 10, 2000
DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
K000091 · JWH
Howmedica Osteonics Corp.
Orthopedic · 57d
Cleared Mar 10, 2000
MODIFICATION TO SYNTHES USS
K000450 · MNI
Synthes Spine
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000453 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Mar 10, 2000
MODIFICATION TO CD SPINAL SYSTEM
K000476 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Mar 10, 2000
GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD
K000575 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 17d
Cleared Mar 10, 2000
ROD TO ROD CROSS BRACES
K000634 · KWQ
Corin USA
Orthopedic · 14d
Cleared Mar 10, 2000
MAGELLAN TIBIAL INTRAMEDULLARY NAIL
K992850 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
MAGELLAN HUMERAL INTRAMEDULLARY NAIL
K992856 · HSB
Orthomatrix, Inc.
Orthopedic · 199d
Cleared Mar 10, 2000
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
K993259 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 163d
Cleared Mar 10, 2000
ZMR HIP SYSTEM-POROUS REVISION
K994286 · LPH
Zimmer, Inc.
Orthopedic · 81d
Cleared Mar 10, 2000
NONLINEAR TAPER LAG SCREW
K994382 · HWC
Theken Surgical
Orthopedic · 73d
Cleared Mar 10, 2000
AEQUALIS SHOULDER FRACTURE SYSTEM
K994392 · KWS
Tornier
Orthopedic · 73d
Cleared Mar 07, 2000
ISOBAR SPINAL SYSTEM
K000425 · MNI
Encore Orthopedics, Inc.
Orthopedic · 27d
Cleared Mar 07, 2000
MODIFICATION TO EBI SPINELINK ANTERIOR CERVICAL SPINAL SYSTEM
K000513 · KWQ
Ebi, L.P.
Orthopedic · 20d
Cleared Mar 06, 2000
SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
K994128 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Mar 06, 2000
THE LIGAMENT ANCHOR SOFT SCREW
K994152 · HWC
Corin USA
Orthopedic · 89d
Cleared Mar 06, 2000
INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS)
K994363 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 70d
Cleared Mar 01, 2000
STAPLETAC2 BONE ANCHOR SYSTEM
K000279 · MBI
American Medical Systems, Inc.
Orthopedic · 30d
Cleared Mar 01, 2000
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
K990330 · JDI
Implex Corp.
Orthopedic · 393d
Cleared Mar 01, 2000
PHALANGEAL FIXATION SYSTEM
K994232 · HTY
Medcanica, Inc.
Orthopedic · 76d
Cleared Feb 28, 2000
TRIPLE-FIX SPINAL FIXATION SYSTEM
K992147 · MNI
Advanced Spine Technology, Inc.
Orthopedic · 249d
Cleared Feb 28, 2000
BLACKSTONE SPINAL FIXATION SYSTEM
K994217 · MNH
Blackstone Medical, Inc.
Orthopedic · 75d