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
14425–14448 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 01, 1996
CPS, CEMENTED HIP SYSTEM
K961899 · JDI
Artos Medical Products GmbH
Orthopedic · 77d
Cleared Aug 01, 1996
HOFFMANN II CARBON CONNECTING ROD
K961916 · JEC
Howmedica, Inc.
Orthopedic · 76d
Cleared Aug 01, 1996
PROTRUSION CAGES
K962007 · JDJ
Depuy, Inc.
Orthopedic · 71d
Cleared Jul 30, 1996
MLI SOFT TISSUE SCREW & WASHER SYSTEM
K962194 · MBI
Medicinelodge, Inc.
Orthopedic · 53d
Cleared Jul 26, 1996
BI-LOC BIPOLAR CUP
K961793 · KWY
Ortho Development Corp.
Orthopedic · 78d
Cleared Jul 26, 1996
COMMAND 2 MICOELECTRIC SURGICAL SYSTEM
K961970 · HWE
Stryker Corp.
Orthopedic · 67d
Cleared Jul 25, 1996
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE...
K960278 · JDI
Zimmer, Inc.
Orthopedic · 188d
Cleared Jul 25, 1996
TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM
K961900 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 70d
Cleared Jul 24, 1996
TITANIUM CANNULATED TIBIAL NAIL (TI CTN)
K962047 · JDS
Synthes (Usa)
Orthopedic · 57d
Cleared Jul 24, 1996
POLARUS AF ROD
K962091 · HSB
Acu Med, Inc.
Orthopedic · 56d
Cleared Jul 23, 1996
DIAO HAND SURGERY SET
K960539 · HXB
Kinetikos Medical, Inc.
Orthopedic · 167d
Cleared Jul 23, 1996
SUBTALAR MBA SYSTEM
K960692 · HWC
Kinetikos Medical, Inc.
Orthopedic · 154d
Cleared Jul 19, 1996
NATURAL-HIP SYSTEM - CALCAR REPLACEMENT HIP STEM
K961727 · LZO
Intermedics Orthopedics
Orthopedic · 77d
Cleared Jul 19, 1996
ARTHOCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM MODEL 970
K962321 · HRX
Arthrocare Corp.
Orthopedic · 32d
Cleared Jul 16, 1996
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K960658 · JDI
Zimmer, Inc.
Orthopedic · 151d
Cleared Jul 16, 1996
ACUFEX TIBIAL ANCHOR SCREW & SPIKED WASHER
K961649 · HWC
Smith & Nephew Endoscopy, Inc.
Orthopedic · 77d
Cleared Jul 15, 1996
STRYKER CEMENT REMOVAL SYSTEM
K961101 · LZV
Stryker Corp.
Orthopedic · 118d
Cleared Jul 15, 1996
ARTHROCARE ARTHROSCOPIC ELECTROSURGERY SYSTEM (MODEL 970)
K961747 · HRX
Arthrocare Corp.
Orthopedic · 70d
Cleared Jul 15, 1996
NATURAL HIP SYSTEM - DRG HIP STEM
K961799 · JDI
Intermedics Orthopedics
Orthopedic · 67d
Cleared Jul 12, 1996
HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM
K954559 · HSD
Howmedica Corp.
Orthopedic · 284d
Cleared Jul 12, 1996
NATURAL HIP SYSTEM
K960258 · JDI
Intermedics Orthopedics
Orthopedic · 176d
Cleared Jul 12, 1996
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
K961619 · JDI
Depuy, Inc.
Orthopedic · 77d
Cleared Jul 10, 1996
ACUFEX TAG BIOABSORBABLE ANCHORS
K961555 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 79d
Cleared Jul 10, 1996
SUTURE ANCHOR
K961578 · JDR
United States Surgical, A Division of...
Orthopedic · 77d