FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
12961–12984 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · KTT
Synthes (Usa)
Orthopedic · 87d
Cleared May 02, 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · KTW
Synthes (Usa)
Orthopedic · 89d
Cleared May 02, 2001
ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR)
K010322 · HSB
Orthodyne, Inc.
Orthopedic · 89d
Cleared Apr 27, 2001
MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION
K003740 · HRX
Aesculap, Inc.
Orthopedic · 144d
Cleared Apr 27, 2001
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K010529 · JDI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 63d
Cleared Apr 26, 2001
SMARTSCREW MODEL 222006...227510
K003077 · HWC
Bionx Implants, Ltd.
Orthopedic · 205d
Cleared Apr 24, 2001
ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS
K011081 · LPH
Exactech, Inc.
Orthopedic · 14d
Cleared Apr 23, 2001
SYNTHES SYNMESH SPACER SYSTEM
K003275 · MQP
Synthes (Usa)
Orthopedic · 186d
Cleared Apr 20, 2001
SYNPLUG
K010840 · LZN
Isotis NV
Orthopedic · 30d
Cleared Apr 18, 2001
TRIDENT POROUS TITANIUM ACETABULAR COMPONENT
K010170 · LPH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 18, 2001
DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS
K010810 · HRY
DePuy Orthopaedics, Inc.
Orthopedic · 30d
Cleared Apr 18, 2001
CLS VARUS STEM/CLS 135 STEM
K010839 · LZO
Sulzer Orthopedics, Inc.
Orthopedic · 28d
Cleared Apr 18, 2001
MODIFICATION TO OSTEONICS SPINAL SYSTEM
K010845 · MNH
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Apr 17, 2001
WUJIN #3 FEMORAL NAIL
K010149 · HSB
Biopro, Inc.
Orthopedic · 90d
Cleared Apr 16, 2001
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K010115 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Apr 13, 2001
AVL HINGE KNEE SYSTEM
K010774 · KRO
Biomet, Inc.
Orthopedic · 30d
Cleared Apr 12, 2001
MOSS MIAMI 5.5MM TITANIUM PIN NUT
K010742 · MNH
Depuyacromed
Orthopedic · 30d
Cleared Apr 11, 2001
SOCON SPINAL SYSTEM
K003463 · MNH
Aesculap, Inc.
Orthopedic · 155d
Cleared Apr 11, 2001
TSRH SPINAL SYSTEM
K010720 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Apr 11, 2001
LFIT V40 FEMORAL HEAD COMPONENTS
K010757 · JDI
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Apr 11, 2001
ULNAR HEAD IMPLANT
K010786 · KXE
Avanta Orthopaedics, Inc.
Orthopedic · 27d
Cleared Apr 09, 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · HTY
Synthes (Usa)
Orthopedic · 144d