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
12817–12840 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · KRO
Plus Orthopedics
Orthopedic · 179d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Mitek Products
Orthopedic · 68d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · KWQ
Aesculap, Inc.
Orthopedic · 239d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · MQP
Depuyacromed
Orthopedic · 221d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Ortho Tec, LLC
Orthopedic · 90d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Bonutti Research, Inc.
Orthopedic · 77d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · HWC
Dj Orthopedics, LLC
Orthopedic · 69d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677 · HRX
Medtronic Xomed, Inc.
Orthopedic · 61d
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