Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

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

Filters: Orthopedic ×
17,985 results
17113–17136 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Sep 02, 1986
ACROMED ADS BONE NAIL
K862552 · KTW
Buckman Co., Inc.
Orthopedic · 61d
Cleared Sep 02, 1986
CONCEPT ARTHROSCOPY RASP
K862659 · HTP
Concept, Inc.
Orthopedic · 50d
Cleared Sep 02, 1986
2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP
K862689 · HXX
W.L. Gore & Associates, Inc.
Orthopedic · 49d
Cleared Aug 29, 1986
OMC ORTHOMET CANNULATED SCREW
K862157
Orthomet, Inc.
Orthopedic · 85d
Cleared Aug 29, 1986
WARSAW ORTHOPEDIC CANCELLOUS BONE SCREW
K862230 · HWC
Buckman Co., Inc.
Orthopedic · 79d
Cleared Aug 20, 1986
DOWNS SURGICAL TITANIUM AUTOCOMPRESSION PLATES
K862945
Downs Surgical , Ltd.
Orthopedic · 15d
Cleared Aug 18, 1986
ABC-1000 SMALL JOINT REAMERS
K862933 · HTO
Instrumentation Industries, Inc.
Orthopedic · 14d
Cleared Aug 11, 1986
INTRAMEDULLARY ROD
K861183
The Deca Co.
Orthopedic · 133d
Cleared Aug 11, 1986
ARTHROSCOPE
K862275 · HRX
Comeg USA, Inc.
Orthopedic · 56d