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
7249–7272 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 25, 2013
SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION
K123055 · HRS
Smith & Nephew, Inc.
Orthopedic · 116d
Cleared Jan 23, 2013
ACCULIF TL-PEEK CAGE
K123281 · MAX
Coalign Innovations, Inc.
Orthopedic · 93d
Cleared Jan 23, 2013
GAMMA3 AND T2 RECON TARGETING DEVICES
K123401 · HSB
Stryker Trauma AG
Orthopedic · 79d
Cleared Jan 23, 2013
FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL
K123579 · MBI
Smith & Nephew, Inc.
Orthopedic · 65d
Cleared Jan 23, 2013
TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+
K123982 · KWS
Encore Medical, L.P.
Orthopedic · 28d
Cleared Jan 18, 2013
INNESIS PEEK CAGE
K120464 · MAX
Bk Meditech, Co., Ltd.
Orthopedic · 338d
Cleared Jan 18, 2013
GEMINUS FOSSA SPECIFIC PLATE SYSTEM
K122310 · HRS
Skeletal Dynamics, LLC
Orthopedic · 170d
Cleared Jan 18, 2013
CALIBER SPACERS
K123231 · MAX
Globus Medical, Inc.
Orthopedic · 94d
Cleared Jan 17, 2013
CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM
K102689 · HRS
Conventus Orthopaedics
Orthopedic · 853d
Cleared Jan 16, 2013
NOVATION CROWN CUP LINERS
K121392 · LZO
Exactech, Inc.
Orthopedic · 252d
Cleared Jan 14, 2013
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
K122870 · JWH
Conformis, Inc.
Orthopedic · 117d
Cleared Jan 14, 2013
ACCULIF TL AND PL CAGE
K123752 · MAX
Coalign Innovations, Inc.
Orthopedic · 39d
Cleared Jan 11, 2013
CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE
K121254 · MAX
Camber Spine Technologies
Orthopedic · 261d
Cleared Jan 11, 2013
MTF NEW BONE VOID FILLER
K121313 · MQV
Musculoskeletal Transplant Foundation
Orthopedic · 254d
Cleared Jan 11, 2013
SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
K121765 · OLO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 210d
Cleared Jan 10, 2013
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
K122771 · OVE
Spinal Elements, Inc.
Orthopedic · 122d
Cleared Jan 10, 2013
OPTETRAK LOGIC CRC TIBIAL INSERT
K123342 · JWH
Exactech, Inc.
Orthopedic · 71d
Cleared Jan 09, 2013
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL...
K122336 · MBI
Eleven Blade Solutions, Inc.
Orthopedic · 160d
Cleared Jan 09, 2013
STRYKER CROSSFLOW ARTHROSCOPY PUMP
K123441 · HRX
Stryker Endoscopy
Orthopedic · 62d
Cleared Jan 08, 2013
ASAP MUITISCOPE
K121261 · HRX
Asap Endoscopic Products GmbH
Orthopedic · 257d
Cleared Jan 08, 2013
AEQUALIS ASCEND FLEX SHOULDER SYSTEM
K122698 · KWS
Tornier S.A.S.
Orthopedic · 126d
Cleared Jan 08, 2013
FALCON SPACER
K123180 · MAX
Synthes USA Products, LLC
Orthopedic · 90d
Cleared Jan 08, 2013
MEGA 5.5 SPINE SYSTEM
K123476 · MNH
Lsk Biopartners, Inc.
Orthopedic · 56d
Cleared Jan 04, 2013
INSTINCT JAVA SYSTEM
K122592 · MNH
Zimmer Spine
Orthopedic · 133d