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
11113–11136 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 18, 2005
WAGNER SL REVISION STEM LATERAL
K043356 · LZO
Zimmer Austin, Inc.
Orthopedic · 133d
Cleared Apr 18, 2005
NOVEL VBR SPINAL SYSTEM
K050553 · MQP
Alphatec/Nexmed
Orthopedic · 46d
Cleared Apr 15, 2005
THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10
K050101 · HRS
Zimmer Trabecular
Orthopedic · 87d
Cleared Apr 15, 2005
ARTHERX CORKSCREW FT II SUTURE ANCHOR
K050358 · HWC
Arthrex, Inc.
Orthopedic · 60d
Cleared Apr 15, 2005
MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004
K050699 · JDK
Amedica Corp.
Orthopedic · 28d
Cleared Apr 11, 2005
ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER
K042565 · LPH
Ortho Development Corp.
Orthopedic · 202d
Cleared Apr 11, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053 · KWP
Medtronic Sofamor Danek
Orthopedic · 157d
Cleared Apr 11, 2005
OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER
K050490 · MQV
Medicrea
Orthopedic · 45d
Cleared Apr 11, 2005
SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO)
K050607 · HRS
Synthes (Usa)
Orthopedic · 32d
Cleared Apr 11, 2005
STRYKER SPINE AVS PL PEEK SPACER
K050624 · MQP
Stryker Spine
Orthopedic · 31d
Cleared Apr 11, 2005
SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION
K050631 · LXT
Synthes (Usa)
Orthopedic · 31d
Cleared Apr 11, 2005
GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G,...
K050666 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 28d
Cleared Apr 11, 2005
EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE
K050675 · MNI
Depuy Spine, Inc.
Orthopedic · 26d
Cleared Apr 11, 2005
ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM
K050761 · KWT
Zimmer, Inc.
Orthopedic · 18d
Cleared Apr 11, 2005
LANX ANTERIOR CERVICAL PLATE SYSTEM
K050774 · KWQ
Lanx, LLC
Orthopedic · 17d
Cleared Apr 11, 2005
MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM
K050804 · KWQ
Aesculap, Inc.
Orthopedic · 12d
Cleared Apr 11, 2005
CHARLOTTE SNAP-OFF SCREW
K050819 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 11d
Cleared Mar 29, 2005
OSSAPLAST ORTHO
K050416 · MQV
Ossacur AG
Orthopedic · 39d
Cleared Mar 29, 2005
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
K050539 · JWH
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Mar 25, 2005
DYNAGRAFT II
K040419 · MQV
Isotis Orthobiologics, Inc.
Orthopedic · 401d
Cleared Mar 25, 2005
BIOLOX DELTA CERAMIC HEADS
K042091 · LZO
Biomet, Inc.
Orthopedic · 234d
Cleared Mar 25, 2005
MAESTRO CARPAL HEMIARTHROPLASTY
K050028 · KWN
Biomet Manufacturing, Inc.
Orthopedic · 78d
Cleared Mar 25, 2005
BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET
K050497 · HWC
Linvatec Corp.
Orthopedic · 25d
Cleared Mar 24, 2005
ENCORE REVERSE SHOULDER PROSTHESIS
K041066 · PHX
Encore Medical, L.P.
Orthopedic · 335d