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
13465–13488 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 09, 1999
MENISCUS ARROW, MODELS 531110, 531113, 531116
K993453 · MAI
Bionx Implants, Ltd.
Orthopedic · 27d
Cleared Nov 08, 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326 · MNI
Scien'Tx USA, Inc.
Orthopedic · 203d
Cleared Nov 08, 1999
TITANIUM HARTSHILL SYSTEM
K991662 · KWP
Surgicraft , Ltd.
Orthopedic · 178d
Cleared Nov 08, 1999
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
K992621 · HRX
Advanced Diagnostics & Interventions
Orthopedic · 95d
Cleared Nov 08, 1999
ISOBAR SPINAL SYSTEM
K992738 · MNI
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 08, 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 67d
Cleared Nov 08, 1999
DIGIT WIDGET
K992970 · JDW
Hand Biomechanics Lab, Inc.
Orthopedic · 66d
Cleared Nov 05, 1999
DEPUY TOTAL ELBOW SYSTEM
K992656 · JDC
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Nov 02, 1999
SYNTHES CERCLAGE POSITIONING PIN
K992891 · JDQ
Synthes (Usa)
Orthopedic · 67d
Cleared Oct 29, 1999
MASS (MICRO-ACCESS SPINE SYSTEM)
K992583 · HRX
Omni-Tract Surgical, Div. Minn....
Orthopedic · 88d
Cleared Oct 27, 1999
SDB CERCLAGE SYSTEM
K992616 · JDQ
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
HEX BUTTON
K992617 · HTN
Pioneer Surgical Technology
Orthopedic · 84d
Cleared Oct 27, 1999
ZMR HIP SYSTEM-REVISION TAPER
K992667 · LPH
Zimmer, Inc.
Orthopedic · 79d
Cleared Oct 27, 1999
NEXT GENERATION RODDING SYSTEM
K992784 · KWQ
United States Surgical, A Division of...
Orthopedic · 69d
Cleared Oct 27, 1999
ROTORBLADE SUTURE ANCHOR
K993373 · MAI
Li Medical Technologies, Inc.
Orthopedic · 20d
Cleared Oct 25, 1999
FLEXIBLE FIBERSCOPES & ACCESSORIES
K990397 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 258d
Cleared Oct 25, 1999
3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90...
K992837 · KTW
Synthes (Usa)
Orthopedic · 63d
Cleared Oct 25, 1999
HYDROCISION ARTHROJET SYSTEM WITH CAUTERY
K993009 · HRX
Hydrocision, Inc.
Orthopedic · 48d
Cleared Oct 22, 1999
REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS
K991026 · LPH
Smith & Nephew, Inc.
Orthopedic · 207d
Cleared Oct 22, 1999
HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS
K993181 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Oct 21, 1999
BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
K992899 · KWS
Biomet, Inc.
Orthopedic · 52d
Cleared Oct 15, 1999
BUECHEL-PAPPAS HUMERAL HEAD RESURFACING COMPONENT
K992394 · HSD
Endotec, Inc.
Orthopedic · 88d
Cleared Oct 14, 1999
CONTOUR SPINAL SYSTEM
K990986 · KWP
Ortho Development Corp.
Orthopedic · 204d
Cleared Oct 14, 1999
RC MULTISUTURE BONE ANCHOR, MODEL 4453/4454
K992458 · MBI
Innovasive Devices, Inc.
Orthopedic · 83d