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
11593–11616 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 14, 2004
ALTIUS OCT SYSTEM
K033961 · KWP
Interpore Cross Intl.
Orthopedic · 114d
Cleared Apr 14, 2004
SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS
K040331 · HWC
Smith & Nephew, Inc.
Orthopedic · 63d
Cleared Apr 12, 2004
ART ANTERIOR SPINAL SYSTEM
K033148 · KWQ
Advanced Medical Technologies AG
Orthopedic · 195d
Cleared Apr 12, 2004
NUVASIVE SPINAL SYSTEM
K033546 · MNH
Nuvasive, Inc.
Orthopedic · 152d
Cleared Apr 12, 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · MBH
Howmedica Osteonics Corp.
Orthopedic · 112d
Cleared Apr 12, 2004
SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM
K040336 · HSB
Synthes (Usa)
Orthopedic · 61d
Cleared Apr 12, 2004
CERAMIC TIPPED SKULL PIN
K040363 · LYT
The Jerome Group, Inc.
Orthopedic · 59d
Cleared Apr 12, 2004
LANX ANTERIOR CERVIAL PLATE SYSTEM
K040401 · KWQ
Lanx, LLC
Orthopedic · 55d
Cleared Apr 12, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES
K040593 · HRS
Zimmer, Inc.
Orthopedic · 35d
Cleared Apr 12, 2004
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K040762 · JDS
Synthes (Usa)
Orthopedic · 18d
Cleared Apr 12, 2004
SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS
K040765 · JDW
Synthes (Usa)
Orthopedic · 18d
Cleared Apr 08, 2004
MODIFICATION TO GEO STRUCTURE
K040168 · MQP
Interpore Cross Intl.
Orthopedic · 73d
Cleared Apr 08, 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Apr 02, 2004
OSTEOSET DBM PELLETS, MODEL 8600-48XX
K022828 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 585d
Cleared Apr 02, 2004
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · KWQ
Depuyacromed
Orthopedic · 64d
Cleared Apr 01, 2004
OSTEOSORB TACK FIXATION SYSTEM
K030989 · JEY
Noviace Corporation
Orthopedic · 370d
Cleared Apr 01, 2004
SYNTHES AFS
K032534 · NQW
Synthes Spine
Orthopedic · 230d
Cleared Apr 01, 2004
KYPHX HV-R, MODEL C01A
K033801 · NDN
Kyphon, Inc.
Orthopedic · 115d
Cleared Mar 31, 2004
BIOCRYL RAPIDE INTERFERENCE SCREW
K032717 · HWC
Mitek Worldwide
Orthopedic · 211d
Cleared Mar 31, 2004
BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM
K033702 · MQP
Blackstone Medical, Inc.
Orthopedic · 127d
Cleared Mar 31, 2004
MERLIN SPINE SYSTEM
K033901 · NKB
Depuy Spine, Inc.
Orthopedic · 105d
Cleared Mar 31, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K040583 · MNI
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Mar 31, 2004
HERCULON SOFT TISSUE REATTACHMENT SYSTEM
K040594 · HWC
United States Surgical, A Division of...
Orthopedic · 23d
Cleared Mar 26, 2004
FIXION HIP SYSTEM
K032730 · JDI
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 205d