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
16969–16992 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 19, 1986
AUSTIN MOORE HIP PROSTHESIS
K863896
Kirschner Medical Corp.
Orthopedic · 43d
Cleared Nov 19, 1986
EFTEKHAR RECHANNELIZATION DRILL GUIDE
K864314 · HSZ
The Anspach Effort, Inc.
Orthopedic · 16d
Cleared Oct 31, 1986
XENON LIGHT SOURCE FOR ENDOSCOPIC PROCEDURES
K863986 · HRX
American Edwards Laboratories
Orthopedic · 17d
Cleared Oct 29, 1986
CANCELLOUS SCREW
K862990 · HRX
Orthopedic Systems, Inc.
Orthopedic · 82d
Cleared Oct 29, 1986
LIGAMENT WASHER
K862991 · HRX
Orthopedic Systems, Inc.
Orthopedic · 82d
Cleared Oct 27, 1986
UNIVERSAL ACETABULAR COMPONENT
K861433 · JDI
Biomet, Inc.
Orthopedic · 194d
Cleared Oct 23, 1986
UNIVERSAL CANNULA SYSTEM
K863590 · HRX
Aspen Laboratories, Inc.
Orthopedic · 38d
Cleared Oct 20, 1986
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS
K863734 · HTY
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 27d
Cleared Oct 15, 1986
EXACTECH TOTAL HIP SYSTEM
K862234 · JDI
Exactech, Inc.
Orthopedic · 126d
Cleared Oct 06, 1986
FEMORAL HEMI-HIP PROSTHESIS
K862460 · KWY
Orthopaedic Device Corp.
Orthopedic · 98d
Cleared Oct 06, 1986
THACKRAY CRUCIATE SPARING KNEE CS-1
K863554
Thackray USA
Orthopedic · 24d
Cleared Oct 03, 1986
ARTHROSCOPIC IRRIGATION PUMP
K863605 · HRX
American Edwards Laboratories
Orthopedic · 17d
Cleared Sep 29, 1986
BICONDYLAR TOE PROSTHESIS
K863528
Depuy, Inc.
Orthopedic · 19d
Cleared Sep 25, 1986
AMERICAN EDWARDS 4.0 MM ARTHROSCOPE
K863597 · HRX
American Edwards Laboratories
Orthopedic · 10d
Cleared Sep 15, 1986
SUPERFIXATION(TM)
K863343 · KTT
Orthopaedic Device Corp.
Orthopedic · 17d
Cleared Sep 12, 1986
CONCEPT INTRAVISION ARTHROSCOPE SYSTEM
K863396 · HRX
Concept, Inc.
Orthopedic · 9d
Cleared Sep 08, 1986
SUTTER LESSER METATARSAL CAP
K861983 · KWD
Sutter Biomedical, Inc.
Orthopedic · 109d
Cleared Sep 08, 1986
HALL CANNLULA SYSTEM
K862778 · HRX
Hall Surgical, Division of Zimmer, Inc.
Orthopedic · 48d
Cleared Sep 05, 1986
BOWEN SUTURE PASSER
K863146 · HXI
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
GLENOID DRILL
K863147 · HTW
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN KNOT PASSER
K863148 · HXI
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 05, 1986
BOWEN PROBE
K863149 · HXB
Bowen & Company, Inc.
Orthopedic · 21d
Cleared Sep 03, 1986
CANNULATED LAG SCREWS
K863119 · HTY
Downs Surgical , Ltd.
Orthopedic · 20d
Cleared Sep 02, 1986
OSTEONICS SHOULDER PROSTHESIS
K862535 · KWS
Osteonics Corp.
Orthopedic · 62d