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
11593–11616 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 28, 2004
QUATRO M FEMORAL COMPONENT
K033313 · LWJ
Whiteside Biomechanics, Inc.
Orthopedic · 287d
Cleared Jul 28, 2004
KAPP CUSTOM ULNAR HEAD WRIST IMPLANT
K033930 · KXE
Kapp Surgical Instrument, Inc.
Orthopedic · 223d
Cleared Jul 28, 2004
MACROPORE HYDROSORB SPINE SYSTEM
K041105 · KWQ
Macropore Biosurgery, Inc.
Orthopedic · 89d
Cleared Jul 28, 2004
ARTHROJET XT
K041233 · HRX
Hydrocision, Inc.
Orthopedic · 79d
Cleared Jul 28, 2004
RESORBABLE INTERFERENCE SCREW
K041274 · HWC
Arthrotek, Inc.
Orthopedic · 77d
Cleared Jul 23, 2004
EQUESTRA FLUID DELIVERY SYSTEM
K040483 · HRX
Medtronic Sofamor Danek, Inc.
Orthopedic · 149d
Cleared Jul 23, 2004
LIFE SPINE NEO ANTERIOR CERVICAL PLATE SYSTEM
K040844 · KWQ
Life Spine, LLC
Orthopedic · 113d
Cleared Jul 23, 2004
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM
K041167 · NKB
Pioneer Surgical Technology
Orthopedic · 80d
Cleared Jul 23, 2004
NORIAN SRS FAST SET PUTTY
K041842 · MQV
Synthes (Usa)
Orthopedic · 15d
Cleared Jul 22, 2004
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
K041085 · JWH
Depuy, Inc.
Orthopedic · 87d
Cleared Jul 22, 2004
PEEK CEMENT RESTRICTOR X-BOX
K041583 · JDK
Innovasis, Inc.
Orthopedic · 41d
Cleared Jul 22, 2004
SUPER REVO HERCULINE SUTURE ANCHOR
K041713 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Jul 20, 2004
ZIMMER ANATOMIC II HIP PROSTHESIS
K041109 · LPH
Zimmer, Inc.
Orthopedic · 83d
Cleared Jul 19, 2004
EXPEDIUM SPINE SYSTEM
K041119 · KWP
Depuy Spine, Inc.
Orthopedic · 81d
Cleared Jul 19, 2004
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
K041794 · KWQ
Interpore Cross Intl.
Orthopedic · 17d
Cleared Jul 14, 2004
ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE...
K040980 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 09, 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 154d
Cleared Jul 09, 2004
KYPHX XPANDER INFLATABLE BONE TAMPS MODEL#KO8A,KO9A,K13A
K041454 · HRX
Kyphon, Inc.
Orthopedic · 38d
Cleared Jul 09, 2004
PROFEMUR S HIP STEM
K041586 · JDL
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared Jul 07, 2004
COPSIOS BONE VOID FILLER (BVF)
K033679 · MQV
Centerpulse Spine-Tech, Inc.
Orthopedic · 226d
Cleared Jul 07, 2004
HOURGLASS VERTEBRAL BODY SPACER
K033926 · MQP
Medtronic Sofamor Danek
Orthopedic · 202d
Cleared Jul 07, 2004
KYPHX HV-R BONE CEMENT, MODEL C01A
K041584 · NDN
Kyphon, Inc.
Orthopedic · 23d
Cleared Jul 06, 2004
3DKNEE POROUS COATED FEMORAL COMPONENT
K032905 · MBH
Encore Orthopedics, Inc.
Orthopedic · 293d
Cleared Jul 06, 2004
OPTIMESH 500E CEMENT RESTRICTOR
K033953 · JDK
Spineology, Inc.
Orthopedic · 197d