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
10753–10776 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 07, 2005
ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS,...
K052607 · HWC
Arthrex, Inc.
Orthopedic · 46d
Cleared Nov 07, 2005
IGNITE BONE VOID FILLER KIT
K052913 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 21d
Cleared Nov 04, 2005
LIGAFIX RESORBABLE INTERFERENCE SCREW, MODELS 30 AND 60
K050407 · HWC
Sciences For Bio Materials
Orthopedic · 260d
Cleared Nov 04, 2005
STRYKER SPINE AVS ASL PEEK SPACER
K051205 · MQP
Stryker Spine
Orthopedic · 177d
Cleared Nov 04, 2005
SYNTHES (USA) SPHERICAL WASHERS
K052483 · NDG
Synthes (Usa)
Orthopedic · 56d
Cleared Nov 03, 2005
GENEROS 80, GENEROS 60
K051914 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 112d
Cleared Nov 03, 2005
ASCENSION MUH
K052137 · KXE
Ascension Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 03, 2005
NOVABONE-BIOACTIVE SYNTHETIC GRAFT
K052494 · MQV
Novabone Products, LLC
Orthopedic · 52d
Cleared Nov 03, 2005
KIMBA SPINAL IMPLANT
K052533 · MQP
Signus Medizintechnik GmbH
Orthopedic · 49d
Cleared Nov 03, 2005
ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT
K052736 · HTY
Arthrex, Inc.
Orthopedic · 34d
Cleared Oct 28, 2005
MODIFICATION TO:CD HORIZON SPINAL SYSTEM
K052747 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Oct 27, 2005
ORTHOPEDIC SALVAGE SYSTEM- OSS
K052685 · KRO
Biomet, Inc.
Orthopedic · 29d
Cleared Oct 27, 2005
V40 BIOLOX DELTA CERAMIC FEMORAL HEADS
K052718 · LZO
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Oct 27, 2005
WRIST FUSION PLATE
K052754 · LXT
Dvo Extremity Solutions, LLC
Orthopedic · 27d
Cleared Oct 26, 2005
GII SPINAL FIXATION SYSTEM
K051089 · MNH
Co-Ligne AG
Orthopedic · 181d
Cleared Oct 26, 2005
GLOBAL RESURFACING UNICOMPARTMENTAL KNEE SYSTEM
K051721 · HRY
Global Orthopaedic Technology, USA, Inc.
Orthopedic · 121d
Cleared Oct 25, 2005
OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
K051656 · HRX
Osteobiologics, Inc.
Orthopedic · 126d
Cleared Oct 25, 2005
COLLAGEN BONE HEALING PROTECTIVE SHEET
K052041 · HRS
Collagen Matrix, Inc.
Orthopedic · 89d
Cleared Oct 21, 2005
AVON PATELLO-FEMORAL JOINT PROSTHESIS
K051948 · KRR
Howmedica Osteonics Corp.
Orthopedic · 95d
Cleared Oct 21, 2005
PINNACLE CONSTRAINED ACETABULAR LINERS
K052079 · KWZ
DePuy Orthopaedics, Inc.
Orthopedic · 80d
Cleared Oct 21, 2005
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · KWQ
X-Spine Systems, Inc.
Orthopedic · 59d
Cleared Oct 21, 2005
SHOULDER NAIL PLATE
K052294 · HRS
Hand Innovations, LLC
Orthopedic · 59d
Cleared Oct 21, 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K052609 · NKB
Medtronic Sofamor Danek
Orthopedic · 29d
Cleared Oct 21, 2005
SUPER QUICKANCHOR PLUS (WITH ORTHOCORD SUTURE)
K052631 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 25d