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
7249–7272 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 13, 2013
PIPELINE TOTAL HIP SYSTEM
K131237 · LPH
Pipeline Orthopedics
Orthopedic · 43d
Cleared Jun 12, 2013
VUSION CS PLUS
K122588 · ODP
Ortho Development Corp.
Orthopedic · 292d
Cleared Jun 12, 2013
SMR 3-PEGS GLENOIDS
K130642 · KWS
Lima Corporate S.P.A.
Orthopedic · 93d
Cleared Jun 10, 2013
HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM
K130907 · KTT
Stryker Trauma AG
Orthopedic · 70d
Cleared Jun 10, 2013
ACUMED TOTALW RIST FUSION PLATING SYSTEM
K131380 · HRS
Acumed, LLC
Orthopedic · 27d
Cleared Jun 07, 2013
4WEB OSTEOTOMY BONE WEDGE
K130185 · HRS
4-Web, Inc.
Orthopedic · 133d
Cleared Jun 07, 2013
LIMACORPORATE SMR CTA HUMERAL HEADS
K131112 · KWS
Lima Corporate S.P.A.
Orthopedic · 46d
Cleared Jun 06, 2013
U2 HIP SYSTEM, EXPANDED INDICATIONS FOR USE
K130149 · LPH
United Orthopedic Corporation
Orthopedic · 135d
Cleared Jun 05, 2013
PIONEER ASPECT ANTERIOR CERVICAL PLATE SYSTEM
K130427 · KWQ
Pioneer Surgical Technology, Inc.
Orthopedic · 105d
Cleared Jun 05, 2013
CD HORIZON SPINAL SYSTEM
K131321 · OSH
Medtronic Sofamor Danek USA
Orthopedic · 28d
Cleared Jun 04, 2013
INFILL OBLIQUE TLIF DEVICE
K124012 · MAX
Pinnacle Spine Group, LLC
Orthopedic · 159d
Cleared Jun 04, 2013
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
K130640 · KWQ
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 85d
Cleared May 31, 2013
STRIDE UNICONDYLAR KNEE
K123380 · HSX
Blue Belt Technologies, Inc.
Orthopedic · 211d
Cleared May 31, 2013
UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM
K130129 · KWS
Arthrex, Inc.
Orthopedic · 134d
Cleared May 31, 2013
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267 · MNH
Spineart
Orthopedic · 116d
Cleared May 31, 2013
MEDLINE CANNULATED SCREW
K130319 · HWC
Medline Industries, Inc.
Orthopedic · 112d
Cleared May 31, 2013
OSTEOMED EXTREMIFUSE SYSTEM
K130412 · HWC
Osteomed
Orthopedic · 101d
Cleared May 31, 2013
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
K130498 · MBP
Bacterin International, Inc.
Orthopedic · 94d
Cleared May 31, 2013
ARS SCREW
K130954 · HWC
Advanced Interventional Technology, LLC
Orthopedic · 56d
Cleared May 31, 2013
PELVIS II IMPLANT SYSTEM
K131132 · HRS
Stryker Trauma AG
Orthopedic · 38d
Cleared May 31, 2013
MAXTORQUE SCREW SYSTEM
K131324 · HWC
Orthohelix Surgical Designs, Inc.
Orthopedic · 23d
Cleared May 30, 2013
ALEUTIAN SPINAL SYSTEM
K130699 · MAX
K2m, Inc.
Orthopedic · 77d
Cleared May 30, 2013
RAMPART O
K131216 · MAX
Spineology, Inc.
Orthopedic · 30d
Cleared May 28, 2013
CORIN TRINITY ACETABULAR SYSTEM WITH EXTRA-LONG HEADS
K130343 · LZO
Corin USA
Orthopedic · 106d