FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,766 results
12721–12744 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 23, 2001
WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL...
K003618 · NDD
Whiteside Biomechanics, Inc.
Orthopedic · 182d
Cleared May 23, 2001
SYNTHES ANTEROLATERAL CALCANEAL PLATE
K010518 · KTT
Synthes (Usa)
Orthopedic · 90d
Cleared May 23, 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared May 23, 2001
MONARCH SPINE SYSTEM
K010576 · MNI
Depuyacromed
Orthopedic · 85d
Cleared May 23, 2001
LACTOSORB PLATES, MESHES, AND PANELS/SHEETS
K011237 · HRS
Biomet, Inc.
Orthopedic · 30d
Cleared May 18, 2001
ASCENT KNEE SYSTEM
K011219 · JWH
Biomet, Inc.
Orthopedic · 28d
Cleared May 17, 2001
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
K010101 · JWH
Kinamed, Inc.
Orthopedic · 126d
Cleared May 17, 2001
EBI DYNAFIX VS OSTEOTOMY SYSTEM
K010551 · NDF
Ebi, L.P.
Orthopedic · 80d
Cleared May 16, 2001
TETHER ACFS
K010466 · KWQ
Theken Surgical,Llc
Orthopedic · 89d
Cleared May 16, 2001
MODIFIED MOSS MIAMI 4.35MM DIAMETER POLYAXIAL SCREWS
K011182 · MNH
Depuyacromed
Orthopedic · 28d
Cleared May 16, 2001
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K011218 · JDI
Exactech, Inc.
Orthopedic · 26d
Cleared May 14, 2001
ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924
K010457 · MBI
Arthrex, Inc.
Orthopedic · 87d
Cleared May 11, 2001
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K003504 · KRO
Plus Orthopedics
Orthopedic · 179d
Cleared May 09, 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · HWC
Mitek Products
Orthopedic · 68d
Cleared May 08, 2001
MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
K002824 · KWQ
Aesculap, Inc.
Orthopedic · 239d
Cleared May 08, 2001
SURGICAL TITANIUM MESH SYSTEM
K003043 · MQP
Depuyacromed
Orthopedic · 221d
Cleared May 08, 2001
BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR
K003735 · MNI
Blackstone Medical, Inc.
Orthopedic · 155d
Cleared May 08, 2001
CLARIS PLATE SYSTEM
K010369 · MNH
Ortho Tec, LLC
Orthopedic · 90d
Cleared May 08, 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · HTY
Bonutti Research, Inc.
Orthopedic · 77d
Cleared May 08, 2001
DJ ORTHOPEDICS INTERFERENCE SCREW
K010595 · HWC
Dj Orthopedics, LLC
Orthopedic · 69d
Cleared May 07, 2001
XPS 3000 SYSTEM
K010677 · HRX
Medtronic Xomed, Inc.
Orthopedic · 61d
Cleared May 04, 2001
MODIFICATION TO TSRH SPINAL SYSTEM
K011067 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared May 04, 2001
APEX FIXATION PINS
K011136 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared May 03, 2001
ADJUSTABLE LARGE FIXATOR SYSTEM
K010344 · KTT
Synthes (Usa)
Orthopedic · 87d