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
11857–11880 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 27, 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · MNH
U&I Corp., America
Orthopedic · 37d
Cleared Jun 27, 2003
CD HORIZON SPINAL SYSTEM
K031655 · MNI
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared Jun 27, 2003
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K031888 · MNI
Medtronic Sofamor Danek
Orthopedic · 9d
Cleared Jun 26, 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · MNH
Blackstone Medical, Inc.
Orthopedic · 122d
Cleared Jun 26, 2003
MINILOK QUICKANCHOR PLUS
K030995 · HWC
Mitek Worldwide
Orthopedic · 87d
Cleared Jun 26, 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Jun 25, 2003
EBI XFIX DFS SYSTEM
K031645 · KTT
Ebi, L.P.
Orthopedic · 28d
Cleared Jun 24, 2003
MODIFICATION TO COLORADO 2 SPINAL SYSTEM
K030875 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 96d
Cleared Jun 24, 2003
SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X
K031154 · JDW
Sintea Biotech, Inc.
Orthopedic · 74d
Cleared Jun 24, 2003
ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923
K031572 · LPH
Zimmer, Inc.
Orthopedic · 35d
Cleared Jun 24, 2003
U & I AMERICA SPINAL HOOK SYSTEM
K031595 · KWP
U&I Corp., America
Orthopedic · 34d
Cleared Jun 24, 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · KTT
Synthes (Usa)
Orthopedic · 21d
Cleared Jun 23, 2003
DEPUY ACROMED VBR SYSTEM
K031635 · MQP
Depuyacromed
Orthopedic · 27d
Cleared Jun 19, 2003
INION OTPS BIODEGRADABLE FIXATON SYSTEM
K030900 · HWC
Inion , Ltd.
Orthopedic · 87d
Cleared Jun 18, 2003
ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03
K031452 · KWP
Ortho Tec, LLC
Orthopedic · 42d
Cleared Jun 18, 2003
INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY
K031605 · HRX
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Jun 13, 2003
VANTAGE ANTERIOR FIXATION SYSTEM
K031533 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Jun 12, 2003
BLACKSTONE POSTERIOR CERVICAL SYSTEM
K030197 · KWP
Blackstone Medical, Inc.
Orthopedic · 142d
Cleared Jun 12, 2003
OTI BONE CEMENT PLUG
K030608 · JDK
Osteoimplant Technology, Inc.
Orthopedic · 106d
Cleared Jun 12, 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · LPH
Biomet, Inc.
Orthopedic · 86d
Cleared Jun 12, 2003
OPUS MAGNUM IMPLANT SYSTEM, MODEL OM-1500
K031083 · HTY
Opus Medical, Inc.
Orthopedic · 69d
Cleared Jun 11, 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Jun 10, 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS...
K030519 · JEC
Hand Biomechanics Lab, Inc.
Orthopedic · 111d
Cleared Jun 09, 2003
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
K031609 · HRS
Swiss Orthopedic Solutions, Inc.
Orthopedic · 18d