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
11257–11280 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 26, 2004
EXACTECH EQUINOXE SHOULDER SYSTEM
K042021 · KWS
Exactech, Inc.
Orthopedic · 90d
Cleared Oct 22, 2004
SMARTMIX PRE-FILLED MIXING SYSTEM
K042591 · KIH
DePuy Orthopaedics, Inc.
Orthopedic · 29d
Cleared Oct 21, 2004
OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221...
K042305 · MQV
Ossacur AG
Orthopedic · 57d
Cleared Oct 20, 2004
SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEM
K041961 · HWC
Scandius Biomedical, Inc.
Orthopedic · 91d
Cleared Oct 20, 2004
ARTHROTEK MENISCAL HYBRID DEVICE
K041988 · JDR
Biomet, Inc.
Orthopedic · 89d
Cleared Oct 18, 2004
ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED
K033943 · KWA
Centerpulse Orthopedics, Inc.
Orthopedic · 304d
Cleared Oct 13, 2004
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED...
K042271 · JWH
Zimmer, Inc.
Orthopedic · 51d
Cleared Oct 08, 2004
FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM
K041353 · MEH
Jri Manufacturing, Ltd.
Orthopedic · 141d
Cleared Oct 08, 2004
T2 PROXIMAL HUMERAL NAIL
K042396 · HSB
Howmedica Osteonics Corp.
Orthopedic · 36d
Cleared Oct 08, 2004
DORSAL INTRAMEDULLARY PLATE
K042437 · HRS
Deo Volente Orthopaedics, LLC
Orthopedic · 30d
Cleared Oct 08, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042524 · KWP
Medtronic Sofamor Danek
Orthopedic · 21d
Cleared Oct 07, 2004
MAESTRO TOTAL WRIST
K042032 · JWJ
Biomet, Inc.
Orthopedic · 71d
Cleared Oct 07, 2004
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
K042135 · HSB
Synthes (Usa)
Orthopedic · 59d
Cleared Oct 07, 2004
EXCELLA-M SPINAL SYSTEM
K042143 · KWP
Innovasis, Inc.
Orthopedic · 59d
Cleared Oct 07, 2004
NOVEL VBR SPINAL SYSTEM
K042201 · MQP
Alphatec/Nexmed
Orthopedic · 55d
Cleared Oct 07, 2004
TITANIUM TELEGRAPH HUMERAL NAIL
K042332 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 38d
Cleared Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · HWC
Synthes (Usa)
Orthopedic · 37d
Cleared Oct 07, 2004
LOCON VLS DISTAL RADIUS PLATE SYSTEM
K042358 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 07, 2004
SYNTHES LOW PROFILE RECONSTRUCTION PLATES
K042377 · HRS
Synthes (Usa)
Orthopedic · 36d
Cleared Oct 07, 2004
IIIZAROV PULLEY SYSTEM
K042436 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 07, 2004
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
K042440 · HSB
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458 · LXT
A.M. Surgical, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · KWP
Medtronic Sofamor Danek
Orthopedic · 23d