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
11689–11712 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 27, 2004
PLUS PIVOT LINK UNIVERSAL SYSTEM
K033508 · MNI
Spine Vision, Inc.
Orthopedic · 82d
Cleared Jan 27, 2004
SHIRAZ-JAVA SPINAL FIXATION SYSTEM
K033772 · MNI
Spine Next America
Orthopedic · 55d
Cleared Jan 22, 2004
POSTERIOR CABLE SCREW
K022908 · MNI
Pioneer Surgical Technology
Orthopedic · 506d
Cleared Jan 22, 2004
SPACER G TEMPORARY HIP PROSTHESIS
K031841 · KWL
Exactech, Inc.
Orthopedic · 220d
Cleared Jan 20, 2004
GII SPINAL FIXATION SYSTEM
K032604 · MNH
Co-Ligne AG
Orthopedic · 148d
Cleared Jan 20, 2004
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM
K032641 · MEH
Portland Orthopaedics Pty. , Ltd.
Orthopedic · 146d
Cleared Jan 20, 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · KTT
Howmedica Osteonics Corp.
Orthopedic · 78d
Cleared Jan 16, 2004
ZIMMER UNICOMPARTMENTAL KNEE SYSTEM
K033363 · HSX
Zimmer, Inc.
Orthopedic · 87d
Cleared Jan 15, 2004
BIODHOC
K024185 · HTY
Future Medical Systems, SA
Orthopedic · 392d
Cleared Jan 15, 2004
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED)
K032108 · MBH
Aesculap, Inc.
Orthopedic · 191d
Cleared Jan 15, 2004
TRANS1 TRANS-SACRAL SPINAL ACCESS AND PREPARATION KIT
K032891 · HRX
Trans1, Inc.
Orthopedic · 120d
Cleared Jan 15, 2004
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
K033342 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Jan 15, 2004
SMALL BONE FIXATION SYSTEM
K033406 · HTY
Hand Innovations, Inc.
Orthopedic · 83d
Cleared Jan 15, 2004
ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM
K033639 · HWC
Acumed, LLC
Orthopedic · 56d
Cleared Jan 15, 2004
ADVANCE DOUBLE HIGH INSERT
K033890 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jan 15, 2004
ARTHOSCOPY PUMP A115
K033927 · HRX
W.O.M. World of Medicine AG
Orthopedic · 28d
Cleared Jan 15, 2004
GAMMA3 NAIL SYSTEM
K034002 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Jan 13, 2004
THE ANSWER SCREW SUPPLEMENTATION SYSTEM
K032966 · HWC
Simplicity Orthopedic Solutions, LLC
Orthopedic · 112d
Cleared Jan 13, 2004
MODIFICATION TO JET-X HA COATED HALF PINS
K033289 · JDW
Smith & Nephew, Inc.
Orthopedic · 91d
Cleared Jan 13, 2004
EBI TOP LOADING MAS SPINAL FIXATION SYSTEM
K033312 · NKB
Ebi, L.P.
Orthopedic · 91d
Cleared Jan 13, 2004
SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM
K033556 · KTT
Synthes (Usa)
Orthopedic · 62d
Cleared Jan 12, 2004
ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
K033286 · HSB
Orthopedic Designs, Inc. (Odi)
Orthopedic · 90d
Cleared Jan 08, 2004
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
K031962 · JWH
Implex Corp.
Orthopedic · 197d
Cleared Jan 08, 2004
PROMOS SHOULDER
K032126 · HSD
Plus Orthopedics
Orthopedic · 182d