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
9361–9384 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 06, 2008
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE
K081979 · MQV
Apatech , Ltd.
Orthopedic · 118d
Cleared Nov 06, 2008
VITOSS BONE GRAFT SUBSTITUTE, BONE GRAFT SUBSTITUTE FILLED CANISTER, FOAM &...
K083033 · MQV
Orthovita, Inc.
Orthopedic · 27d
Cleared Nov 05, 2008
MODIFICATION TO 4CIS VANE SPINE SYSTEM
K081145 · MNI
Solco Biomedical Co., Ltd.
Orthopedic · 197d
Cleared Nov 05, 2008
INDEPENDENCE SPACER
K082252 · OVD
Globus Medical, Inc.
Orthopedic · 89d
Cleared Nov 05, 2008
DARCO SMALL SCREW
K082320 · HWC
Wrightmedicaltechnologyinc
Orthopedic · 84d
Cleared Nov 03, 2008
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA...
K082078 · HRS
Zimmer, Inc.
Orthopedic · 103d
Cleared Nov 03, 2008
OSTEORAPTOR SUTURE ANCHOR
K082215 · JDR
Smith & Nephew Inc., Endoscopy Division
Orthopedic · 89d
Cleared Oct 31, 2008
STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT
K080979 · KWY
Biomet Manufacturing Corp
Orthopedic · 207d
Cleared Oct 31, 2008
SPINESMITH PARTNERS, LP CEQUENCE ANTERIOR CERVICAL PLATE SYSTEM
K082821 · KWQ
Spine Smith Partners L.P.
Orthopedic · 36d
Cleared Oct 31, 2008
MODFICATION TO: EXPEDIUM SPINE SYSTEM
K082942 · NKB
Depuy Spine, Inc.
Orthopedic · 29d
Cleared Oct 30, 2008
UNITY BETA ANCHOR SYSTEM
K082906 · HWC
Bonutti Research, Inc.
Orthopedic · 30d
Cleared Oct 24, 2008
AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
K082120 · KWS
Tornier
Orthopedic · 88d
Cleared Oct 24, 2008
VANGUARD CR STEM HOUSINGS
K082826 · JWH
Biomet Manufacturing Corp
Orthopedic · 29d
Cleared Oct 24, 2008
DISTAL RADIO-ULNAR JOINT IMPLANT
K082839 · KXE
Aptis Medical, LLC
Orthopedic · 28d
Cleared Oct 22, 2008
EVOLIS TOTAL KNEE SYSTEM
K081023 · JWH
Medacta International S.A.
Orthopedic · 195d
Cleared Oct 22, 2008
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II
K082088 · KRR
Mako Surgical Corp.
Orthopedic · 90d
Cleared Oct 21, 2008
ULTRASLIDE ACROMIOCLAVICULAR AND SYNDESMOTIC REPAIR DEVICE
K082095 · HTN
Smith & Nephew Endoscopy, Inc.
Orthopedic · 89d
Cleared Oct 21, 2008
LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE
K082774 · MAX
Lanx, LLC
Orthopedic · 29d
Cleared Oct 17, 2008
ACCIN TOTAL KNEE SYSTEM
K081127 · JWH
Accelerated Innovation, LLC
Orthopedic · 179d
Cleared Oct 17, 2008
TENODESIS CROSS SCREW, INTERFERENCE SCREW, SUTURE BEAD
K081348 · MBI
TriMed, Inc.
Orthopedic · 156d
Cleared Oct 17, 2008
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES
K082260 · MAX
Calvary Spine, LLC
Orthopedic · 70d
Cleared Oct 17, 2008
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM
K082375 · HTY
OrthoPediatrics Corp.
Orthopedic · 60d
Cleared Oct 17, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K082797 · NKB
Blackstone Medical, Inc.
Orthopedic · 24d
Cleared Oct 16, 2008
SPINAL USA VBR SYSTEM
K081196 · MAX
Spinal USA
Orthopedic · 171d