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
10249–10272 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 20, 2006
MOZAIK BONE REGENERATION MATRIX - PUTTY
K062353 · MQV
Integra LifeSciences Corporation
Orthopedic · 131d
Cleared Dec 20, 2006
TRIDENT II ACETABULAR SYSTEM
K063616 · LZO
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Dec 19, 2006
X-STEN MILD TOOL KIT, MODEL MTK-0001
K062038 · HRX
X-Sten Corp.
Orthopedic · 153d
Cleared Dec 19, 2006
CITADEL ANTERIOR LUMBAR PLATE SYSTEM
K062836 · KWQ
Globus Medical, Inc.
Orthopedic · 90d
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEM
K063497 · MAI
Scandius Biomedical, Inc.
Orthopedic · 29d
Cleared Dec 19, 2006
MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM
K063499 · MBI
Scandius Biomedical, Inc.
Orthopedic · 29d
Cleared Dec 18, 2006
PROGENIX DBM PUTTY AND PASTE
K060794 · MBP
Medtronic Sofamor Danek
Orthopedic · 270d
Cleared Dec 18, 2006
MOBIS SPINAL IMPLANT
K061082 · MQP
Signus Medizintechnik GmbH
Orthopedic · 244d
Cleared Dec 18, 2006
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049 · HRS
Synthes (Usa)
Orthopedic · 75d
Cleared Dec 18, 2006
LORENZ STERNAL CLOSURE SYSTEM
K063506 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 28d
Cleared Dec 15, 2006
BF+ (PH)
K061462 · MQV
Ldr Spine USA
Orthopedic · 203d
Cleared Dec 15, 2006
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K062426 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 119d
Cleared Dec 15, 2006
VERSALOK ANCHOR WITH FREE STRANDS OF ORTHOCORD SUTURE (210808), ETHIBOND...
K063478 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 28d
Cleared Dec 14, 2006
FLOSIMPLE ARTHROSCOPY PUMP A120
K062380 · HRX
W.O.M. World of Medicine AG
Orthopedic · 121d
Cleared Dec 14, 2006
INTAI BONE PLATE AND BONE SCREW SYSTEM
K063020 · HRS
Intai Technology, Inc.
Orthopedic · 73d
Cleared Dec 14, 2006
APERFIX TIBIAL IMPLANT WITH INSERTER
K063070 · HWC
Cayenne Medical, Inc.
Orthopedic · 69d
Cleared Dec 13, 2006
NFIX II PEDICLE SCREW SYSTEM
K061774 · NQP
N-Spine, Inc.
Orthopedic · 173d
Cleared Dec 13, 2006
MODULAR REPLACEMENT ELBOW SYSTEM
K062845 · HSD
Howmedica Osteonics Corp.
Orthopedic · 82d
Cleared Dec 13, 2006
ARTHREX PUSHLOCK
K063479 · HWC
Arthrex, Inc.
Orthopedic · 26d
Cleared Dec 12, 2006
MODIFICATION TO: FMP METAL/METAL ACETABULAR INSERT, MODELS 499-28, 499-34,...
K063414 · KWA
Encore Medical, L.P.
Orthopedic · 29d
Cleared Dec 11, 2006
MODULAR HYBRID GLENOID
K060694 · KWS
Biomet Manufacturing Corp
Orthopedic · 271d
Cleared Dec 11, 2006
XIA STAINLESS STEEL SPINAL SYSTEM
K063428 · NKB
Stryker Spine
Orthopedic · 28d
Cleared Dec 08, 2006
ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS
K062997 · LZO
Biomet Manufacturing Corp
Orthopedic · 67d
Cleared Dec 07, 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · HRS
Acumed, LLC
Orthopedic · 22d