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
11329–11352 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 04, 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL...
K042776 · LPH
Zimmer, Inc.
Orthopedic · 29d
Cleared Nov 04, 2004
BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE
K042778 · HWC
Linvatec Corp.
Orthopedic · 29d
Cleared Nov 04, 2004
CD HORIZON SPINAL SYSTEM
K042790 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Nov 04, 2004
C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM
K042798 · KWQ
Interpore Cross Intl.
Orthopedic · 27d
Cleared Nov 01, 2004
VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS
K042093 · HRY
Biomet, Inc.
Orthopedic · 90d
Cleared Oct 29, 2004
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K041100 · MBH
Zimmer, Inc.
Orthopedic · 185d
Cleared Oct 29, 2004
TI - SCREW ANCHOR SP
K042460 · MBI
Arthrotek, Inc.
Orthopedic · 49d
Cleared Oct 29, 2004
PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES
K042598 · HRS
Zimmer, Inc.
Orthopedic · 36d
Cleared Oct 29, 2004
NCB PLATING SYSTEM
K042695 · HRS
Zimmer GmbH
Orthopedic · 29d
Cleared Oct 27, 2004
EBI CAS SPINE SPACER SYSTEM
K042268 · MQP
Ebi, L.P.
Orthopedic · 65d
Cleared Oct 27, 2004
SYNTHES (USA) LCP WRIST FUSION PLATES
K042355 · HRS
Synthes (Usa)
Orthopedic · 57d
Cleared Oct 27, 2004
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K042673 · KWP
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 26, 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · KWS
Exactech, Inc.
Orthopedic · 90d
Cleared Oct 22, 2004
SMARTMIX PRE-FILLED MIXING SYSTEM
K042591 · KIH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Oct 21, 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221...
K042305 · MQV
Ossacur AG
Orthopedic · 57d
Cleared Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
K041961 · HWC
Scandius Biomedical, Inc.
Orthopedic · 91d
Cleared Oct 20, 2004
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · JDR
Biomet, Inc.
Orthopedic · 89d
Cleared Oct 18, 2004
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
K033943 · KWA
Centerpulse Orthopedics, Inc.
Orthopedic · 304d
Cleared Oct 13, 2004
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED...
K042271 · JWH
Zimmer, Inc.
Orthopedic · 51d
Cleared Oct 08, 2004
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
K041353 · MEH
Jri Manufacturing, Ltd.
Orthopedic · 141d
Cleared Oct 08, 2004
T2 PROXIMAL HUMERAL NAIL
K042396 · HSB
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Oct 08, 2004
DORSAL INTRAMEDULLARY PLATE
K042437 · HRS
Deo Volente Orthopaedics, LLC
Orthopedic · 30d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 07, 2004
MAESTRO TOTAL WRIST
K042032 · JWJ
Biomet, Inc.
Orthopedic · 71d