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
13009–13032 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 24, 2000
MACROSORBOS PROTECTIVE SHEET
K994158 · HRS
Macropore Biosurgery, Inc.
Orthopedic · 228d
Cleared Jul 20, 2000
MODIFICATION TO OMEGA 21 SYSTEM
K001357 · KWQ
Ebi, L.P.
Orthopedic · 83d
Cleared Jul 20, 2000
TI-MAX PROTRUSIO CAGE
K001376 · JDI
Biomet, Inc.
Orthopedic · 80d
Cleared Jul 20, 2000
SYNTHES CERVIFIX SYSTEM
K001864 · KWQ
Synthes Spine
Orthopedic · 30d
Cleared Jul 20, 2000
TORNIER CEMENT RESTRICTOR
K001932 · JDI
Tornier
Orthopedic · 24d
Cleared Jul 19, 2000
MODIFICATION TO CENTAUR SPINAL SYSTEM
K001844 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Jul 19, 2000
GEM KNEE SYSTEM
K994214 · JWH
Kinamed, Inc.
Orthopedic · 218d
Cleared Jul 14, 2000
SAMARCO SPIDER PLATES
K001271 · KTW
Biomet, Inc.
Orthopedic · 85d
Cleared Jul 12, 2000
EBI ANTERIOR CERVICAL PLATE SYSTEM
K001794 · KWQ
Ebi, L.P.
Orthopedic · 28d
Cleared Jul 12, 2000
APEX FIXATION PINS
K001886 · JDW
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 11, 2000
THE KALIX IMPLANT
K001231 · HWC
New Deal, S.A.
Orthopedic · 85d
Cleared Jul 11, 2000
CD HORIZON SPINAL SYSTEM
K001255 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 83d
Cleared Jul 07, 2000
EXTERNAL FIXATION ANCHOR PIN
K001228 · JDW
Immedica, Inc.
Orthopedic · 81d
Cleared Jul 07, 2000
SULZER ORTHOPEDICS INC. NATURAL-HIP SYSTEM LD STEM
K001320 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 72d
Cleared Jul 07, 2000
POROCOAT PRODIGY HIP PROSTHESIS
K001778 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jul 05, 2000
IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE
K983667 · MQP
Ionics Medical Corp.
Orthopedic · 625d
Cleared Jun 29, 2000
SPINE SYSTEM EVOLUTION
K001080 · KWP
Aesculap, Inc.
Orthopedic · 86d
Cleared Jun 27, 2000
MODIFIED SINGLE AXLE TOTAL ELBOW
K000683 · JDC
Biomet, Inc.
Orthopedic · 119d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jun 23, 2000
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
K000827 · KRR
Walter Abendschein, M.D.
Orthopedic · 101d
Cleared Jun 23, 2000
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K001078 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 80d
Cleared Jun 23, 2000
TRIFLANGE ACETABULAR CUP SYSTEM
K001277 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jun 22, 2000
ANATOMIC TOTAL KNEE PROSTHESIS
K000978 · JWH
Biomet, Inc.
Orthopedic · 87d
Cleared Jun 22, 2000
CD HORIZON ECLIPSE
K001066 · MNH
Medtronic Sofamor Danek, Inc.
Orthopedic · 80d