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
11953–11976 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635 · MQP
Depuyacromed
Orthopedic · 27d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · HWC
Inion , Ltd.
Orthopedic · 87d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · KWP
Ortho Tec, LLC
Orthopedic · 42d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · KWP
Blackstone Medical, Inc.
Orthopedic · 142d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608 · JDK
Osteoimplant Technology, Inc.
Orthopedic · 106d
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · LPH
Biomet, Inc.
Orthopedic · 86d
Cleared Jun 12, 2003
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
K031083 · HTY
Opus Medical, Inc.
Orthopedic · 69d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS...
K030519 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 111d
Cleared Jun 09, 2003
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
K031609 · HRS
Swiss Orthopedic Solutions, Inc.
Orthopedic · 18d
Cleared Jun 06, 2003
MSD CABLE REDUCTION SYSTEM
K030816 · KWP
Medtronic Sofamor Danek
Orthopedic · 84d
Cleared Jun 06, 2003
PLUS ORTHOPEDICS CEMENTED HIP STEM
K031165 · JDI
Plus Orthopedics
Orthopedic · 53d
Cleared Jun 06, 2003
CUFFLOK ANCHOR
K031519 · MAI
Mitek Worldwide
Orthopedic · 22d
Cleared Jun 06, 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · KTT
Synthes (Usa)
Orthopedic · 17d
Cleared Jun 04, 2003
BIO-MODULAR SHOULDER SYSTEM
K030710 · KWT
Biomet, Inc.
Orthopedic · 90d
Cleared Jun 03, 2003
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · LZO
Zimmer, Inc.
Orthopedic · 88d
Cleared Jun 02, 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · HWC
Karl Storz Endoscopy
Orthopedic · 77d
Cleared May 30, 2003
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K023887 · HWC
Inion , Ltd.
Orthopedic · 190d
Cleared May 30, 2003
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
K030972 · KWL
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 63d
Cleared May 30, 2003
EXOJET TISSUE MANAGEMENT SYSTEM
K031406 · HRX
Mitek Worldwide
Orthopedic · 25d
Cleared May 30, 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · JDQ
Synthes (Usa)
Orthopedic · 16d
Cleared May 28, 2003
ENCORE ANTERIOR SPINAL STAPLE SYSTEM
K030667 · KWQ
Encore Medical, L.P.
Orthopedic · 86d