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
7201–7224 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Feb 27, 2013
INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)
K123672 · HWC
Inion OY
Orthopedic · 90d
Cleared Feb 27, 2013
PICCOLO COMPOSITE PLATE SYSTEM
K130061 · HRS
CarboFix Orthopedics , Ltd.
Orthopedic · 48d
Cleared Feb 27, 2013
SIMMETRY SACROILIAC JOINT FUSION SYSTEM
K130092 · OUR
Zyga Technology, Inc.
Orthopedic · 43d
Cleared Feb 27, 2013
SPEEDLOCK KNOTLESS FIXATION DEVICE, 3MM DRILL, 3MM+ DRILL, PATHFINDER...
K130196 · MBI
Arthrocare Corp.
Orthopedic · 30d
Cleared Feb 25, 2013
POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
K123549 · NKB
Biomet Spine (Aka Ebi, LLC)
Orthopedic · 98d
Cleared Feb 25, 2013
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
K123656 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 89d
Cleared Feb 22, 2013
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS,...
K122015 · KRO
Howmedica Osteonics Corp.
Orthopedic · 227d
Cleared Feb 22, 2013
U-MOTION II ACETABULAR SYSTEM
K122185 · LZO
United Orthopedic Corp.
Orthopedic · 214d
Cleared Feb 22, 2013
ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM
K123459 · MBH
Zimmer, Inc.
Orthopedic · 105d
Cleared Feb 22, 2013
CD HORIZON SPINAL SYSTEM
K123809 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 73d
Cleared Feb 22, 2013
PERSONA NATURAL TIBIA BASEPLATES
K130143 · JWH
Zimmer, Inc.
Orthopedic · 31d
Cleared Feb 21, 2013
LUCENT
K122967 · MAX
Spinal Elements, Inc.
Orthopedic · 149d
Cleared Feb 21, 2013
CINCHLOCK KNOTLESS SUTURE ANCHOR
K123651 · MBI
Pivot Medical
Orthopedic · 86d
Cleared Feb 20, 2013
TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL
K123425 · MBI
Smith & Nephew, Inc.
Orthopedic · 105d
Cleared Feb 15, 2013
SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA...
K122518 · ODP
Bm Korea Co., Ltd.
Orthopedic · 182d
Cleared Feb 15, 2013
SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM
K123164 · MNH
Spinefrontier, Inc.
Orthopedic · 129d
Cleared Feb 15, 2013
GRIDLOCK PLATING SYSTEM
K123525 · HRS
Trilliant Surgical, Ltd.
Orthopedic · 92d
Cleared Feb 14, 2013
A200 KNEE SYSTEM
K120038 · OIY
Renovis Surgical Technologies, LLC
Orthopedic · 406d
Cleared Feb 14, 2013
TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS...
K123166 · JWH
Howmedica Osteonics Corp.
Orthopedic · 128d
Cleared Feb 14, 2013
SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT
K123240 · MBI
ArthroCare Corporation
Orthopedic · 121d
Cleared Feb 14, 2013
ILLICO MIS POSTERIOR FIXATION SYSTEM
K123623 · NKB
Alphatec Spine, Inc.
Orthopedic · 83d
Cleared Feb 14, 2013
MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM
K123918 · HRS
Zimmer, Inc.
Orthopedic · 57d
Cleared Feb 13, 2013
INTEGRA PROXIMAL HUMERAL PLATE SYSTEM
K121826 · HRS
Ascension Orthopedics, Inc.
Orthopedic · 237d
Cleared Feb 13, 2013
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS
K123412 · OSH
K2m, Inc.
Orthopedic · 99d