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
11449–11472 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 05, 2004
VILEX BONE PLATE SYSTEM
K041287 · HWC
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 05, 2004
TALUS OF VILEX (TOV)
K041289 · HWC
Vilex, Inc.
Orthopedic · 84d
Cleared Aug 04, 2004
PORE-SI BONE GRAFT SUBSTITUTE
K040082 · MQV
Apatech , Ltd.
Orthopedic · 202d
Cleared Aug 02, 2004
ALLOMATRIX PUTTY
K041168 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Jul 30, 2004
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157 · HTY
Hand Innovations, Inc.
Orthopedic · 88d
Cleared Jul 30, 2004
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K041352 · KRO
Biomet, Inc.
Orthopedic · 71d
Cleared Jul 30, 2004
HUMERAL STAPLE
K041355 · HTY
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 30, 2004
ANTERIOR COMPACT SYSTEM
K041469 · KWQ
X-Spine Systems
Orthopedic · 58d
Cleared Jul 29, 2004
SUTURE ARROW
K041128 · MAI
Linvatec Corp.
Orthopedic · 90d
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