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
8521–8544 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 08, 2010
UNITED U2 BIPOLAR IMPLANT
K101670 · KWY
United Orthopedic Corp.
Orthopedic · 116d
Cleared Oct 07, 2010
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
K101939 · HSB
Merete Medical GmbH
Orthopedic · 87d
Cleared Oct 07, 2010
EXCELLA II SPINAL SYSTEM MODEL EC2-00
K102248 · NKB
Innovasis, Inc.
Orthopedic · 59d
Cleared Oct 06, 2010
PARADIGM INTERSPINOUS FUSION PLATE
K093438 · KWP
Paradigm Spine, LLC
Orthopedic · 336d
Cleared Oct 06, 2010
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
K100123 · HRS
Acumed, LLC
Orthopedic · 264d
Cleared Oct 06, 2010
CONSENSUS CS2 PLUS ACETABULAR INSERT
K100933 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 184d
Cleared Oct 06, 2010
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K102277 · MAX
Vertebral Technologies, Inc.
Orthopedic · 56d
Cleared Oct 05, 2010
JOURNEY UNICONDYLAR TIBIAL BASEPLATES
K102069 · HSX
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared Oct 04, 2010
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM
K092723 · HRX
Skeletal Dynamics, LLC
Orthopedic · 395d
Cleared Oct 04, 2010
CASPIAN SPINAL SYSTEM
K101084 · KWP
K2m, Inc.
Orthopedic · 168d
Cleared Oct 01, 2010
DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM
K100042 · MAX
Difusion Technologies
Orthopedic · 266d
Cleared Oct 01, 2010
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS
K101622 · HSB
Zimmer, Inc.
Orthopedic · 114d
Cleared Sep 30, 2010
TSRH(R) SPINAL SYSTEM
K101772 · NKB
Medtronic Sofamor Danek
Orthopedic · 98d
Cleared Sep 30, 2010
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
K102090 · OVD
Spine Smith Partners L.P.
Orthopedic · 66d
Cleared Sep 30, 2010
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM DISTAL RADIUS PLATES AND SCREWS
K102156 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 62d
Cleared Sep 30, 2010
PRIMALOK FACET FIXATION SYSTEM
K102438 · MRW
Osteomed LP
Orthopedic · 35d
Cleared Sep 29, 2010
EBERLE SHAVER SYSTEM ACCESSORIES
K092977 · HRX
Efs Eberle Feinwerktechnische Systeme
Orthopedic · 369d
Cleared Sep 29, 2010
DEPUY UNIVERSAL GRIPTION TF CONES
K100391 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 225d
Cleared Sep 29, 2010
LDR SPINE USA C-PLATE, TL ANTERIOR CERVICAL PLATE SYSTEM
K102265 · KWQ
Ldr Spine USA
Orthopedic · 50d
Cleared Sep 28, 2010
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
K091956 · OIY
Encore Medical, L.P.
Orthopedic · 454d
Cleared Sep 28, 2010
SOMONA CWG CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA CWG XYYY(X=DIA,...
K100112 · HSB
Sonoma Orthopedic Products, Inc.
Orthopedic · 257d
Cleared Sep 28, 2010
APEX KNEE MODULAR TIBIA SYSTEM
K101994 · JWH
Omnlife Science
Orthopedic · 75d
Cleared Sep 27, 2010
CD HORIZON SPINAL SYSTEM
K091445 · NKB
Medtronic Sofamor Danek
Orthopedic · 500d
Cleared Sep 27, 2010
SMITH & NEPHEW CIRCULAR FIXATION SYSTEM
K093047 · KTT
Smith & Nephew, Inc.
Orthopedic · 362d