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
7609–7632 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 01, 2012
SMR RESURFACING SHOULDER SYSTEM- HUMERAL HEADS, CTA HUMERAL HEADS
K112900 · HSD
Lima Corporate S.P.A.
Orthopedic · 242d
Cleared May 31, 2012
OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE...
K121307 · JWH
Exactech, Inc.
Orthopedic · 30d
Cleared May 30, 2012
STAINLESS STEEL SPINAL SYSTEM
K120829 · NKB
Theken Spine, LLC
Orthopedic · 72d
Cleared May 29, 2012
SI-FIX SACROILIAC JOINT FUSION SYSTEM
K110472 · OUR
Medtronic Sofamor Danek
Orthopedic · 466d
Cleared May 29, 2012
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
K113561 · MAX
Zimmer Trabecular Metal Technology
Orthopedic · 180d
Cleared May 29, 2012
ORTHO SOLUTIONS TRAUMA PLATES FOR OSTEOSYSNTHESIS
K120360 · HRS
Ortho Solutions Limited
Orthopedic · 113d
Cleared May 25, 2012
I-FUSE HAMMER TOE SYSTEMS
K113006 · HWC
Orthopro, LLC
Orthopedic · 231d
Cleared May 25, 2012
SYNTHES ACIS/VERTEBRAL SPACER CR
K120275 · ODP
Synthes (Usa), LLC
Orthopedic · 116d
Cleared May 25, 2012
RANGE SPINAL SYSTEM, UNIT ROD
K120899 · MNI
K2m, Inc.
Orthopedic · 60d
Cleared May 24, 2012
COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM
K112905 · MBF
Biomet Orthopedics, LLC
Orthopedic · 234d
Cleared May 24, 2012
LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
K120840 · ODP
L & K Biomed Co., Ltd.
Orthopedic · 65d
Cleared May 23, 2012
LUCENT OR LUCENT MAGNUM
K110632 · MAX
Spinal Elements, Inc.
Orthopedic · 446d
Cleared May 23, 2012
TEMPUS CERVICAL PLATE SYSTEM
K120515 · KWQ
Neurostructures, LLC
Orthopedic · 92d
Cleared May 23, 2012
LEXUS CERVICAL FIXATION SYSTEM
K120879 · MNI
L & K Biomed Co., Ltd.
Orthopedic · 61d
Cleared May 22, 2012
TAPER SET HIP SYSTEM RDP STEM
K121263 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 26d
Cleared May 21, 2012
DYNA LOCKING ANKLE NAIL
K120419 · HSB
U&I Corp.
Orthopedic · 101d
Cleared May 18, 2012
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS
K113271 · KWA
Biomet Manufacturing, Inc.
Orthopedic · 196d
Cleared May 18, 2012
R&D INNOVATION PEDICLE SCREW SYSTEM
K120091 · NKB
R&D Innovation, LLC
Orthopedic · 128d
Cleared May 18, 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K120099 · MNI
K2m, Inc.
Orthopedic · 127d
Cleared May 18, 2012
GENESIS II PS NON-MODULAR FEMORAL COMPONENT
K120698 · JWH
Smith & Nephew, Inc.
Orthopedic · 72d
Cleared May 18, 2012
SYNTHES MATRIX SYSTEM
K120928 · NKB
Synthes Spine
Orthopedic · 52d
Cleared May 17, 2012
MINI CANNULATED HEADED AND HEADLESS SCREW SET
K120493 · HWC
Instratek, Inc.
Orthopedic · 90d
Cleared May 16, 2012
VANGUARD SSK 360 REVISION KNEE SYSTEM
K121149 · JWH
Biomet Manufacturing Corp
Orthopedic · 30d
Cleared May 15, 2012
S 100 PEDICLE SCREW SYSTEM
K111940 · MNH
Renovis Surgical Technologies, LLC
Orthopedic · 312d