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
8113–8136 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 21, 2011
COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM
K110320 · HRS
Biomet Manufacturing Corp
Orthopedic · 168d
Cleared Jul 21, 2011
REXIOUS SPINAL FIXATION SYSTEM
K111362 · MNH
Dio Medical Co., Ltd.
Orthopedic · 66d
Cleared Jul 21, 2011
METASURG DIGIFUSE IMPLANT
K111536 · HWC
Metasurg
Orthopedic · 49d
Cleared Jul 21, 2011
SIMMETRY(TM) SACROILIAC JOINT FUSION SYSTEM
K111801 · OUR
Zyga Technology, Inc.
Orthopedic · 24d
Cleared Jul 20, 2011
HEMI IMPLANT
K102401 · KWD
Vilex, Inc.
Orthopedic · 330d
Cleared Jul 20, 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · PHX
Encore Medical, L.P.
Orthopedic · 93d
Cleared Jul 20, 2011
AAP CANNULATED SCREWS
K111316 · HWC
Aap Implantate AG
Orthopedic · 71d
Cleared Jul 20, 2011
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED...
K111399 · MBI
Arthrocare Corp.
Orthopedic · 62d
Cleared Jul 20, 2011
PATHWAY MODEL 07XXXX
K111774 · MAX
Custom Spine
Orthopedic · 27d
Cleared Jul 19, 2011
STAXXSD SYSTEM
K111469 · MQP
Spine Wave, Inc.
Orthopedic · 53d
Cleared Jul 19, 2011
PLATEAU SPACER SYSTEM
K111835 · ODP
Life Spine, Inc.
Orthopedic · 20d
Cleared Jul 18, 2011
CAPSTONE R SPINAL SYSTEM
K103731 · MAX
Medtronic Sofamor Danek
Orthopedic · 208d
Cleared Jul 15, 2011
EXACTECH GIBRALT SPINAL SYSTEM
K110197 · MNI
Exactech, Inc.
Orthopedic · 172d
Cleared Jul 15, 2011
SMR SHOULDER SYSTEM - CTA HUMERAL HEADS
K110847 · KWS
Lima Corporate S.P.A.
Orthopedic · 109d
Cleared Jul 13, 2011
ATLAS SPINE PEDICLE SCREW SYSTEM
K110842 · NKB
Atlas Spine, Inc.
Orthopedic · 110d
Cleared Jul 13, 2011
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
K111062 · JWH
Omni Life Science, Inc.
Orthopedic · 86d
Cleared Jul 12, 2011
ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K101997 · HSB
Ellipse Technologies, Inc.
Orthopedic · 362d
Cleared Jul 12, 2011
PRO FIXATION SYSTEM
K110538 · HWC
Synovis Orthopedic & Woundcare
Orthopedic · 137d
Cleared Jul 12, 2011
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE...
K110670 · HRS
Smith & Nephew, Inc.
Orthopedic · 125d
Cleared Jul 12, 2011
SOLANAS AVALON POSTERIOR FIXATION SYSTEM
K111076 · NKB
Alphatec Spine, Inc.
Orthopedic · 85d
Cleared Jul 12, 2011
ORTHOSORB RESORBABLE PINS
K111077 · OVZ
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Jul 12, 2011
TITAN TI SUTURE ANCHOR SYSTEM
K111397 · MBI
Arthrocare Corp.
Orthopedic · 54d
Cleared Jul 06, 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · NKB
Globus Medical, Inc.
Orthopedic · 156d
Cleared Jul 06, 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE
K110541 · JDQ
Figure 8 Surgical, Incorporated
Orthopedic · 131d