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
14185–14208 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 14, 1997
ISOLA TWISTER CONNECTOR
K965046 · MNH
Acromed Corp.
Orthopedic · 86d
Cleared Mar 13, 1997
TRUE/FIT FEMORAL INTRAMEDULLARY ROD SYSTEM
K961360 · HSB
Encore Orthopedics, Inc.
Orthopedic · 338d
Cleared Mar 13, 1997
IMPLEX REPLACEMENT ACETABULAR CUP INSERT
K964882 · LPH
Implex Corp.
Orthopedic · 98d
Cleared Mar 13, 1997
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K965145 · KWP
Depuy, Inc.
Orthopedic · 80d
Cleared Mar 13, 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · LPH
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
HOWMEDICA MAINSTAY ANCHOR
K965175 · JDR
Howmedica Corp.
Orthopedic · 79d
Cleared Mar 13, 1997
BIORIGID NAIL TIBIA
K970013 · HTY
Aap GmbH and Co. Betriebs KG
Orthopedic · 70d
Cleared Mar 13, 1997
LINK CERCLAGE WIRE SYSTEM
K970084 · JDQ
Turnkey Intergration USA, Inc.
Orthopedic · 63d
Cleared Mar 13, 1997
PROXIMAL FEMORAL NAIL (PFN) SYSTEM
K970097 · JDW
Synthes (Usa)
Orthopedic · 59d
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