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
13369–13392 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 23, 1999
MOSS MIAMI 6.35MM POLYAXIAL SCREW
K992168 · KWQ
Depuyacromed
Orthopedic · 87d
Cleared Sep 23, 1999
SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN)
K992348 · JDS
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 23, 1999
EBI XFIX DYNAFIX SYSTEM HA COATED SCREWS
K992367 · HWC
Electro-Biology, Inc.
Orthopedic · 70d
Cleared Sep 23, 1999
ARTHROSCOPE / MEDIFIX INC.
K992474 · HRX
Medifix, Inc.
Orthopedic · 59d
Cleared Sep 23, 1999
ROTORBLADE SUTURE ANCHOR
K992938 · MAI
Li Medical Technologies, Inc.
Orthopedic · 23d
Cleared Sep 22, 1999
BIOPRO RIMMED ACETABULAR COMPOMENT
K992144 · LZO
Biologically Oriented Prostheses
Orthopedic · 90d
Cleared Sep 22, 1999
PYLON INTRAMEDULLAARY NAIL SYSTEM
K992350 · HSB
Alphatec Mfg., Inc.
Orthopedic · 70d
Cleared Sep 22, 1999
MITEK ROTATOR CUFF QUICKANCHOR PLUS
K992611 · HWC
Mitek Products
Orthopedic · 49d
Cleared Sep 21, 1999
MITEK MINI QUICKANCHOR PLUS
K992487 · HWC
Mitek Products
Orthopedic · 57d
Cleared Sep 21, 1999
CD HORIZON SPINAL SYSTEM
K992928 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 21d
Cleared Sep 21, 1999
CANNULATED SMARTSCREW MODELS 224540C, 224570C
K992947 · HWC
Bionx Implants, Ltd.
Orthopedic · 20d
Cleared Sep 17, 1999
BIOBUTTON
K990194 · HWC
Linvatec Corp.
Orthopedic · 239d
Cleared Sep 17, 1999
MODUS SYSTEM SELF-DRILLING SCREWS
K992106 · HWC
Medartis AG
Orthopedic · 87d
Cleared Sep 17, 1999
COLOR BUFFED CEMENTED FEMORAL
K992903 · JDI
Biomet, Inc.
Orthopedic · 18d
Cleared Sep 14, 1999
DANEK PLATE AND SCREW SYSTEM
K991036 · MNH
Sofamor Danek USA,Inc.
Orthopedic · 169d
Cleared Sep 14, 1999
PREMIER ANTERIOR CERVICAL PLATE SYSTEM
K992110 · KWQ
Sofamor Danek USA
Orthopedic · 84d
Cleared Sep 13, 1999
BIO-MODULAR SHOULDER SYSTEM
K992119 · KWS
Biomet, Inc.
Orthopedic · 82d
Cleared Sep 10, 1999
TRI-POLAR SYSTEM
K991990 · KWY
Biomet, Inc.
Orthopedic · 88d
Cleared Sep 03, 1999
STACKABLE CAGE SYSTEM
K990148 · MQP
Depuy Motech Acromed
Orthopedic · 227d
Cleared Sep 03, 1999
MODULAR RADIAL HEAD
K991915 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Sep 03, 1999
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
K992063 · HSB
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 01, 1999
REUNITE SCREWS
K992301 · HWC
Biomet Manufacturing, Inc.
Orthopedic · 55d
Cleared Sep 01, 1999
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K992570 · KWL
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Aug 27, 1999
PLUS CERAMIC HEAD PROSTHESES (ALUMINA AND ZIRKONIA)
K990261 · LZO
Plus Orthopedics
Orthopedic · 212d