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
13513–13536 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Aug 27, 1999
OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM
K991055 · MNH
Howmedica Osteonics Corp.
Orthopedic · 150d
Cleared Aug 27, 1999
SYNTHES CERVIFIX SYSTEM
K991089 · KWP
Synthes Spine
Orthopedic · 149d
Cleared Aug 27, 1999
DYNA-LOK PLUS SPINAL SYSTEM
K991198 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 141d
Cleared Aug 27, 1999
ANATOMICAL BANKART TACK, MODEL 523520A
K992567 · MAI
Bionx Implants, Ltd.
Orthopedic · 25d
Cleared Aug 26, 1999
OSTEOPLAST, MODEL POP200
K991854 · MQV
Interpore Cross Intl.
Orthopedic · 86d
Cleared Aug 23, 1999
AEQUALIS SHOULDER PROSTHESIS
K980244 · KWS
Tornier
Orthopedic · 577d
Cleared Aug 19, 1999
EBI XFIX DFS RAIL SYSTEM
K991941 · KTT
Electro-Biology, Inc.
Orthopedic · 71d
Cleared Aug 19, 1999
B2C HIP SYSTEM
K992490 · JDI
Lepine Groupe Spa.
Orthopedic · 24d
Cleared Aug 18, 1999
BIPOLAR SHOULDER PROSTHESIS
K991585 · KWT
Biomet, Inc.
Orthopedic · 103d