FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
11257–11280 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Mar 24, 2005
CD HORIZON SPINAL SYSTEM
K050439 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 30d
Cleared Mar 24, 2005
SYNTHES VECTRA SYSTEM
K050451 · KWQ
Synthes Spine Co.Lp
Orthopedic · 30d
Cleared Mar 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043488 · NKB
Medtronic Sofamor Danek
Orthopedic · 94d
Cleared Mar 21, 2005
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K050138 · JDI
Howmedica Osteonics Corp.
Orthopedic · 59d
Cleared Mar 21, 2005
STRYKER LOCKED PLATING SYSTEM
K050512 · HRS
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Mar 21, 2005
MODIFICATION TO: ARTHREX V-TAK
K050634 · HWC
Arthrex, Inc.
Orthopedic · 12d
Cleared Mar 17, 2005
DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX
K040262 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 407d
Cleared Mar 17, 2005
STABILIZATION SCREW
K050346 · HWC
New Deal, S.A.
Orthopedic · 34d
Cleared Mar 16, 2005
EXCIA TOTAL HIP SYSTEM
K042344 · LWJ
Aesculap, Inc.
Orthopedic · 198d