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
13681–13704 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM
K983258 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 21, 1998
MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM
K983260 · MNI
Spinal Concepts, Inc.
Orthopedic · 35d
Cleared Oct 19, 1998
BMP CABLE SYSTEM
K982545 · JDQ
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 16, 1998
ARTHROTEK INTERFERENCE SCREW
K982497 · HWC
Biomet, Inc.
Orthopedic · 88d
Cleared Oct 16, 1998
HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM
K982531 · HRS
Howmedica Corp.
Orthopedic · 88d
Cleared Oct 13, 1998
MINI-FIXATOR FOR COLLES FRACTURES
K982982 · HRS
Biomet, Inc.
Orthopedic · 48d
Cleared Oct 13, 1998
INNOVASIVE TIBIAL FASTENER
K983056 · MBI
Innovasive Devices, Inc.
Orthopedic · 42d
Cleared Oct 08, 1998
EBI VUECATH ENDOSCOPIC SPINAL SYSTEM
K982484 · HRX
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Oct 08, 1998
SYNTHES (USA) DISTAL RADIUS PLATE SYSTEM (DRPS)
K982732 · HRS
Synthes
Orthopedic · 64d
Cleared Oct 07, 1998
ODC B2 BIPOLAR CUP
K982389 · KWY
Ortho Development Corp.
Orthopedic · 90d
Cleared Oct 05, 1998
TENOR SPINAL SYSTEM
K982490 · KWP
Sofamor Danek USA,Inc.
Orthopedic · 80d
Cleared Oct 05, 1998
DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM
K982585 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 73d
Cleared Oct 05, 1998
OTI MODULAR SHOULDER SYSTEM
K982886 · HSD
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared Oct 05, 1998
DEPUY C-STEM SYSTEM
K982918 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 47d
Cleared Oct 05, 1998
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160,...
K983121 · HTY
Syntec Scientific Corp.
Orthopedic · 27d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION
K980484 · MNI
Aesculap, Inc.
Orthopedic · 235d
Cleared Oct 02, 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · HRX
Stryker Endoscopy
Orthopedic · 87d
Cleared Oct 02, 1998
OTI FEMORAL LOCK TOTAL HIP SYSTEM
K982598 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 70d
Cleared Oct 02, 1998
CONTEMPORARY ACETABULAR COMPONENT
K982670 · JDI
Howmedica Corp.
Orthopedic · 63d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
K982914 · MNI
Aesculap, Inc.
Orthopedic · 44d
Cleared Sep 25, 1998
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE MODEL NUMBERS 5RG05,...
K980817 · MQV
Interpore Intl.
Orthopedic · 206d
Cleared Sep 25, 1998
HYDROCISION ARTHROJET SYSTEM
K982266 · HRX
Hydrocision, Inc.
Orthopedic · 88d
Cleared Sep 25, 1998
THE BONE TIE
K982719 · HTY
Surgicraft , Ltd.
Orthopedic · 52d
Cleared Sep 25, 1998
OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS
K983152 · MNH
Osteonics Corp.
Orthopedic · 16d