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
11401–11424 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 08, 2004
STALIF TT
K041617 · MQP
Surgicraft , Ltd.
Orthopedic · 85d
Cleared Sep 08, 2004
LTD POLYAXIAL FIXATION SYSTEM
K041625 · KWQ
Us Spinal Technologies, LLC
Orthopedic · 85d
Cleared Sep 08, 2004
HOFFMANN II FOOT RING
K041706 · KTT
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
NUMELOCK II SYSTEM
K041709 · KTT
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 08, 2004
SCANDIUS ACL RECONSTRUCTION SYSTEM
K041749 · HWC
Scandius Biomedical, Inc.
Orthopedic · 71d
Cleared Sep 08, 2004
CALCAMEA PLATE
K041786 · HRS
New Deal, S.A.
Orthopedic · 69d
Cleared Sep 08, 2004
EXPEDIUM MIS SPINE SYSTEM
K041801 · NKB
Depuy Spine, Inc.
Orthopedic · 68d
Cleared Sep 08, 2004
SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG
K041860 · HRS
Synthes (Usa)
Orthopedic · 61d
Cleared Sep 08, 2004
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL...
K041872 · MBH
Biomet Manufacturing Corp
Orthopedic · 61d
Cleared Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
K041911 · KTT
Synthes (Usa)
Orthopedic · 55d
Cleared Sep 08, 2004
BIOPRO SUBTALAR IMPLANT
K041936 · HWC
Biopro, Inc.
Orthopedic · 51d
Cleared Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
K041965 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Sep 08, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K042167 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 08, 2004
TROCHANTERIC NAIL SYSTEM
K042325 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 12d
Cleared Sep 03, 2004
OUTOLOGOUS SPINAL FIXATION SYSTEM
K040493 · MNI
Orthopedic Sciences, Inc.
Orthopedic · 190d
Cleared Sep 03, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · MNI
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533 · HWC
Synthes (Usa)
Orthopedic · 85d
Cleared Sep 01, 2004
ZIMMER TRABECULAR METAL HUMERAL STEM
K041549 · KWT
Zimmer, Inc.
Orthopedic · 84d
Cleared Aug 31, 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · MQV
Biomet Manufacturing, Inc.
Orthopedic · 127d
Cleared Aug 27, 2004
EXPANDABLE PEEK VBR IMPLANT
K040928 · MQP
Interpore Cross Intl.
Orthopedic · 140d
Cleared Aug 27, 2004
DURASUL BIPOLAR
K040947 · KWY
Centerpulse Orthopedics, Inc.
Orthopedic · 137d
Cleared Aug 27, 2004
SURFIX KNEE OSTEOTOMY SYSTEM
K041601 · HRS
Surfix Technologies
Orthopedic · 74d
Cleared Aug 27, 2004
ENDOTINE FOREHEAD TRIPLE DEVICE
K042078 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Aug 26, 2004
NAME BONE VOID FILLER
K041421 · MQV
Stryker Biotech
Orthopedic · 90d