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
11881–11904 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 11, 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Aug 11, 2003
CD HORIZON SPINAL SYSTEM
K032265 · KWQ
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Aug 08, 2003
HBS HEADLESS BONE SCREW
K030302 · HWC
Schoening & Assoc., Inc.
Orthopedic · 191d
Cleared Aug 08, 2003
OPUS SPINAL SYSTEM
K030369 · NKB
Howmedica Osteonics Corp.
Orthopedic · 185d
Cleared Aug 08, 2003
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
K031428 · LXT
Synthes (Usa)
Orthopedic · 94d
Cleared Aug 08, 2003
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K031702 · KWQ
Howmedica Osteonics
Orthopedic · 67d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · JDI
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · JDK
Interpore Cross Intl.
Orthopedic · 31d
Cleared Aug 08, 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 31d
Cleared Aug 08, 2003
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · MAI
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Aug 08, 2003
VKS/TC-PLUS REVISION KNEE
K032215 · JWH
Plus Orthopedics
Orthopedic · 18d
Cleared Aug 08, 2003
BIORCI SCREW
K032224 · HWC
Smith & Nephew, Inc.
Orthopedic · 18d
Cleared Aug 08, 2003
GAMMA 3 NAIL SYSTEM
K032244 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Aug 08, 2003
MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM
K032264 · HSD
Howmedica Osteonics Corp.
Orthopedic · 16d
Cleared Aug 07, 2003
SPINAL CONCEPTS, INC. INFIX SYSTEM
K031672 · MQP
Spinal Concepts, Inc.
Orthopedic · 69d
Cleared Aug 06, 2003
EBI OMEGA21 SPINAL FIXATION SYSTEM
K031354 · MNI
Ebi, L.P.
Orthopedic · 99d
Cleared Aug 06, 2003
FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
K031401 · KTT
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 93d
Cleared Aug 06, 2003
THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS
K031462 · MBH
Implex Corp.
Orthopedic · 90d
Cleared Aug 06, 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · LPH
Biomet, Inc.
Orthopedic · 65d
Cleared Aug 04, 2003
BONESOURCE BVF
K031435 · MQV
Howmedica Osteonics
Orthopedic · 90d
Cleared Jul 31, 2003
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480 · KRO
Howmedica Osteonics Corp.
Orthopedic · 80d
Cleared Jul 30, 2003
UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS
K031381 · MNI
Seaspine
Orthopedic · 90d
Cleared Jul 30, 2003
PEEK TETRIS SPINAL IMPLANT
K031757 · MQP
Signus Medical, LLC
Orthopedic · 54d
Cleared Jul 30, 2003
VERTE-STACK SPINAL SYSTEM
K031780 · MQP
Medtronic Sofamor Danek
Orthopedic · 50d