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
11641–11664 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 18, 2004
LCP RADIAL HEAD PLATING SYSTEM
K040777 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Jun 17, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040612 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 101d
Cleared Jun 17, 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · KWQ
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jun 17, 2004
ALADYN RIGID SPINE PLATE
K040747 · MNH
Scient'X
Orthopedic · 86d
Cleared Jun 17, 2004
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K040749 · KRO
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Jun 17, 2004
EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE
K040755 · MQV
Exactech, Inc.
Orthopedic · 85d
Cleared Jun 17, 2004
INTEGRA BONE FIXATION SYSTEM
K040860 · HRS
Integra LifeSciences Corporation
Orthopedic · 76d
Cleared Jun 17, 2004
AEQUALIS SHOULDER SYSTEM
K041339 · KWS
Tornier
Orthopedic · 28d
Cleared Jun 15, 2004
SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS
K040701 · HWC
Synthes (Usa)
Orthopedic · 90d
Cleared Jun 14, 2004
CONTOUR HA COATED RECONSTRUCTION RING
K040680 · MEH
Smith & Nephew, Inc.
Orthopedic · 90d
Cleared Jun 14, 2004
STRYKER BIOZIP SUTURE ANCHOR SYSTEM
K041305 · MAI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM
K041307 · MAI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 14, 2004
STRYKER WEDGE SUTURE ANCHOR SYSTEM
K041310 · MBI
Stryker Endoscopy
Orthopedic · 28d
Cleared Jun 10, 2004
JAX-TCP
K033552 · MQV
Smith & Nephew, Inc.
Orthopedic · 211d
Cleared Jun 10, 2004
MODIFICATION TO TSRH SPINAL SYSTEM
K041282 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 10, 2004
MODIFICATION TO SMARTPIN
K041288 · HTY
Linvatec Biomaterials, Inc.
Orthopedic · 28d
Cleared Jun 07, 2004
FEMORAL HOOK
K041261 · MBI
Arthrotek, Inc.
Orthopedic · 27d
Cleared Jun 04, 2004
VERSA-DIAL HUMERAL HEAD
K040610 · KWS
Biomet Manufacturing, Inc.
Orthopedic · 88d
Cleared Jun 04, 2004
MODULAR RADIAL HEAD REPLACEMENT DEVICE
K040611 · KWI
Biomet, Inc.
Orthopedic · 88d
Cleared Jun 04, 2004
EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS
K040613 · MEH
Exactech, Inc.
Orthopedic · 87d
Cleared Jun 03, 2004
PROCYON SPINAL SYSTEM
K033512 · MNH
Nas Medical Technologies, Inc.
Orthopedic · 210d
Cleared Jun 02, 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE...
K033489 · MBH
Biomet, Inc.
Orthopedic · 211d
Cleared Jun 02, 2004
SWIFT ANTERIOR CERVICAL PLATE SYSTEM
K040655 · KWQ
Depuy Spine, Inc.
Orthopedic · 82d
Cleared Jun 02, 2004
SUMMIT OCT SPINAL SYSTEM
K041203 · MNI
Depuy Spine, Inc.
Orthopedic · 26d