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
6865–6888 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 07, 2014
RING-LOK MODULAR BIPOLAR SYSTEM
K132539 · KWY
Implants International, Ltd.
Orthopedic · 178d
Cleared Feb 07, 2014
NB3D BONE VOID FILLER
K132050 · MQV
Pioneer Surgical Technology, Inc.
Orthopedic · 220d
Cleared Feb 07, 2014
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION...
K131966 · LXC
Twin Star Medical, Inc.
Orthopedic · 224d
Cleared Feb 06, 2014
STAPIX SUPERELASTIC IMPLANT BONE STAPLES
K133523 · JDR
Instratek, Inc.
Orthopedic · 83d
Cleared Feb 04, 2014
4.5MM HEALIX ADVANCE BR ANCHOR, WITH 2 OR 3 STRANDS OF #2 PERMACORD SUTURE,...
K133794 · MAI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 53d
Cleared Feb 04, 2014
GFS II STANDARD, GFS II LARGE, GFS MIMI
K133757 · MBI
Parcus Medical, LLC
Orthopedic · 55d
Cleared Feb 04, 2014
ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION
K133737 · JWH
Zimmer, Inc.
Orthopedic · 57d
Cleared Feb 04, 2014
SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM
K132886 · HRS
Smith & Nephew, Inc.
Orthopedic · 141d
Cleared Feb 03, 2014
JULIET LL LATERAL LUMBAR CAGE
K133557 · MAX
Spineart
Orthopedic · 76d
Cleared Feb 03, 2014
DEROYAL SPINE SPACER SYSTEM
K131292 · MAX
Deroyal Industries, Inc.
Orthopedic · 273d
Cleared Jan 31, 2014
INTERBODY CAGE SYSTEM
K133967 · MAX
Aurora Spine
Orthopedic · 38d
Cleared Jan 30, 2014
MINI TIGHTROPE
K133275 · HTN
Arthrex, Inc.
Orthopedic · 98d
Cleared Jan 30, 2014
TITANIUM SUTURE ANCHOR
K133229 · MBI
Mtp Solutions, LLC
Orthopedic · 101d
Cleared Jan 30, 2014
MECTALIF TIPEEK
K133192 · MAX
Medacta International
Orthopedic · 105d
Cleared Jan 30, 2014
ARDIS INTERBODY SYSTEM
K133184 · MAX
Zimmer Spine, Inc.
Orthopedic · 105d
Cleared Jan 30, 2014
CENTURION POCT SYSTEM
K131833 · KWP
Orthofix, Inc.
Orthopedic · 224d
Cleared Jan 28, 2014
EMERGE MEDICAL SMALL AND LARGE NON-LOCKING FRAGMENT PLATE SYSTEM
K133541 · HRS
Emerge Medical
Orthopedic · 71d
Cleared Jan 28, 2014
XTRAFIX SMALL EXTERNAL FIXATION SYSTEM
K131413 · KTT
Zimmer, Inc.
Orthopedic · 257d
Cleared Jan 27, 2014
TRITIUM STERNAL CABLE PLATE SYSTEM
K133785 · JDQ
Pioneer Surgical Technology, Inc.
Orthopedic · 46d
Cleared Jan 27, 2014
PERI-PROSTHETIC CABLE SYSTEM
K133354 · JDQ
Biomet, Inc.
Orthopedic · 88d
Cleared Jan 27, 2014
AVERSION PEDICLE SCREW SYSTEM
K133103 · MNI
K7, LLC
Orthopedic · 119d
Cleared CT Jan 24, 2014
KIVA VCF TREATMENT SYSTEM
K132817 · NDN
Benvenue Medical, Inc.
Orthopedic · 137d
Cleared Jan 23, 2014
AAP LOQTEQ DISTAL ANTEROLATERAL TIBIA PLATE 3.5
K133675 · HRS
Aap Implantate AG
Orthopedic · 55d
Cleared Jan 23, 2014
ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131490 · HSB
Ellipse Technologies, Inc.
Orthopedic · 245d