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
13969–13992 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 30, 1997
OSTEO CANNULATED SCREW SYSTEM
K971800 · HWC
Osteonics Corp.
Orthopedic · 76d
Cleared Jul 30, 1997
VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
K971802 · MBI
Louisville Laboratories, Inc.
Orthopedic · 76d
Cleared Jul 30, 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · LPH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 24, 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789 · JWH
Implex Corp.
Orthopedic · 71d
Cleared Jul 23, 1997
ULTIMA TPS CEMENTED STEM
K965198 · KWL
Johnson & Johnson International
Orthopedic · 209d
Cleared Jul 23, 1997
MICRO-SEAL ACETABULAR SYSTEM
K971718 · LPH
Whiteside Biomechanics, Inc.
Orthopedic · 75d
Cleared Jul 18, 1997
HEMISPHERE CEMENTED CUP
K971581 · JDI
Ortho Development Corp.
Orthopedic · 79d
Cleared Jul 18, 1997
SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM
K971783 · HTY
Synthes (Usa)
Orthopedic · 65d
Cleared Jul 18, 1997
ATLAS FRACTURE PROXIMAL HUMERAL NAIL
K971816 · HSB
Biomet, Inc.
Orthopedic · 63d
Cleared Jul 17, 1997
EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES
K961719 · HRS
Howmedica Leibinger, Inc.
Orthopedic · 441d
Cleared Jul 17, 1997
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
K971189 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 107d
Cleared Jul 17, 1997
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
K971755 · JEC
Howmedica Corp.
Orthopedic · 66d
Cleared Jul 16, 1997
ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS
K971414 · LZO
Smith & Nephew, Inc., Orthopaedic Div.
Orthopedic · 91d
Cleared Jul 16, 1997
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
K971457 · KWP
Arcan Orthopaedic Corp.
Orthopedic · 110d
Cleared Jul 16, 1997
OSTEONICS ANTEVERTED NECK HIP STEM
K971497 · LZO
Osteonics Corp.
Orthopedic · 83d
Cleared Jul 16, 1997
P.F.C. SIGMA INSET PATELLA
K971652 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 71d
Cleared Jul 16, 1997
DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE
K971741 · JDQ
Howmedica Corp.
Orthopedic · 65d
Cleared Jul 09, 1997
34MM SCARF THREAD-HEAD(TM) SCREW
K971068 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
TWIST-OFF (TM) SCREW
K971069 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
SCARF THREAD-HEAD (TM) HEAD SCREW
K971070 · HWC
Landos, Inc.
Orthopedic · 107d
Cleared Jul 09, 1997
OSTEO COMPRESSION CONDYLE SCREW SYSTEM
K971321 · HRS
Osteonics Corp.
Orthopedic · 90d
Cleared Jul 09, 1997
AMS MAINSTAY UROLOGIC BONE ANCHOR
K971332 · MBI
American Medical Systems, Inc.
Orthopedic · 90d
Cleared Jul 09, 1997
BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM
K971358 · MAI
Arthrex, Inc.
Orthopedic · 89d
Cleared Jul 09, 1997
OSTEONICS ALUMINA C-TAPER HEAD
K971409 · LZO
Osteonics Corp.
Orthopedic · 84d