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
14329–14352 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 10, 1997
MITEK SUTURE RETROGRADER
K970360 · HWQ
Mitek Products
Orthopedic · 38d
Cleared Mar 07, 1997
OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION)
K964924 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 88d
Cleared Mar 05, 1997
KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY
K970055 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 57d
Cleared Mar 04, 1997
PNEUMATIC ARTHROSCOPY PULSED IRRIGATOR SYSTEM MODEL 0027030 AND BATTERY...
K964879 · HRX
Davol Inc., Sub. C. R. Bard, Inc.
Orthopedic · 89d
Cleared Feb 28, 1997
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076 · MRW
Sofamor Danek USA,Inc.
Orthopedic · 609d
Cleared Feb 28, 1997
HANSSON PIN SYSTEM
K964893 · JDW
Osteonics Corp.
Orthopedic · 84d
Cleared Feb 28, 1997
OSTEONICS SCREW HOLE PLUGS
K965056 · JDK
Osteonics Corp.
Orthopedic · 72d
Cleared Feb 28, 1997
INTRAMEDULLARY NAIL SYSTEM
K965098 · HSB
Zimmer, Inc.
Orthopedic · 70d
Cleared Feb 28, 1997
MEDNEXT SURGICAL BUR
K970023 · HWE
Mednext, Inc.
Orthopedic · 56d
Cleared Feb 28, 1997
SPINE-TECH BONE HARVESTER
K970040 · HWE
Spine-Tech, Inc.
Orthopedic · 53d
Cleared Feb 28, 1997
HA GLOBAL TAPER (GT) TAPERED HIP STEM
K970337 · MEH
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 30d
Cleared Feb 28, 1997
GLOBAL TAPER SPECTRON HIP STEMS
K970351 · JDI
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 29d
Cleared Feb 27, 1997
9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW
K965073 · HWC
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Feb 27, 1997
SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS
K970567 · KWT
Intermedics Orthopedics
Orthopedic · 14d
Cleared Feb 24, 1997
MITEK ABSORBABLE TOGGLE ANCHOR
K964013 · MAI
Mitek Products
Orthopedic · 140d
Cleared Feb 24, 1997
INNOVASIVE DEVICES ROTATOR CUFF FASTNER
K964945 · MBI
Innovasive Devices, Inc.
Orthopedic · 76d
Cleared Feb 24, 1997
KINEMAX PLUS TIBIAL SPACERS
K964951 · JWH
Howmedica Corp.
Orthopedic · 76d
Cleared Feb 24, 1997
COHORT DISCECTOMY SYSTEMS (CDS)
K964975 · HRX
Cohort Medical Products Group, Inc.
Orthopedic · 74d
Cleared Feb 19, 1997
ANTERIOR DYNAMIZED SYSTEM
K953978 · KWQ
Acromed Corp.
Orthopedic · 546d
Cleared Feb 19, 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 82d
Cleared Feb 19, 1997
STABLELOC II EXTERNAL FIXATOR
K965029 · JEC
Acu Med, Inc.
Orthopedic · 64d
Cleared Feb 19, 1997
PATIENT SPECIFIC IMPLANT HIP FEMORAL COMPONENT
K970346 · LZO
Kairos Orthopaedics
Orthopedic · 20d
Cleared Feb 18, 1997
BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR...
K960363 · MJT
Biomet, Inc.
Orthopedic · 390d
Cleared Feb 18, 1997
STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR...
K965111 · MBI
R. Thomas Grotz, M.D., Inc.
Orthopedic · 60d