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
7921–7944 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 21, 2011
GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5
K112097 · MRW
Exactech, Inc.
Orthopedic · 122d
Cleared Nov 21, 2011
CLYDESDALES SPINAL SYSTEM
K112405 · MAX
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 91d
Cleared Nov 21, 2011
PASS LP SPINAL SYSTEM
K112493 · MNI
Medicrea International
Orthopedic · 84d
Cleared Nov 21, 2011
S4 SPINAL SYSTEM
K112551 · NKB
Aesculap Implant System, Inc.
Orthopedic · 81d
Cleared Nov 21, 2011
DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM
K112724 · KWQ
Medos International SARL
Orthopedic · 63d
Cleared Nov 21, 2011
CD HORIZON SPINAL SYSTEM
K113174 · NKB
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 25d
Cleared Nov 18, 2011
SYNTHES USS
K111358 · NKB
Synthes Spine
Orthopedic · 186d
Cleared Nov 18, 2011
GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
K111593 · NDN
Bm Korea Co., Ltd.
Orthopedic · 164d
Cleared Nov 18, 2011
VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX
K111983 · ODP
Zimmer Trabecular Metal Technology
Orthopedic · 129d
Cleared Nov 17, 2011
SYNTHES LCP PEDIATRIC PLATE SYSTEMS
K112085 · HRS
Synthes USA Products, LLC
Orthopedic · 119d
Cleared Nov 17, 2011
MEMOMETAL INTRA-MEDULLARY BONE FASTENER
K112197 · HTY
Memometal Technologies
Orthopedic · 108d
Cleared Nov 15, 2011
RSP GLENOID BASEPLATE POROUS COATED
K112069 · PHX
Encore Medical, L.P.
Orthopedic · 118d
Cleared Nov 15, 2011
ANATOMIC PEEK CERVICAL FUSION SYSTEM
K112444 · ODP
Medtronic Sofamor Danck USA, Inc.
Orthopedic · 83d
Cleared Nov 15, 2011
STERISPINEPS PEDICLE SCREW
K112453 · NKB
Safe Orthopaedics
Orthopedic · 82d
Cleared Nov 14, 2011
FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
K102413 · HSB
Vilex, Inc.
Orthopedic · 447d
Cleared Nov 14, 2011
ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM
K111843 · OLO
Smith & Nephew Inc., Endoscopy Div.
Orthopedic · 138d
Cleared Nov 14, 2011
ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR
K112111 · HTN
Acumed, LLC
Orthopedic · 112d
Cleared Nov 14, 2011
PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES
K112406 · HRS
Smith & Nephew, Inc.
Orthopedic · 84d
Cleared Nov 10, 2011
KNOTLESS SUTURE FIXATION SYSTEM
K111716 · MBI
Core Essence Orthopaedics
Orthopedic · 143d
Cleared Nov 10, 2011
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER
K113019 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Nov 09, 2011
NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM
K110442 · ODP
Nanovis, LLC
Orthopedic · 266d
Cleared Nov 09, 2011
TELAMON PEEK SPINAL SYSTEM
K110562 · MAX
Medtronic Sofamor Danek USA
Orthopedic · 254d
Cleared Nov 09, 2011
HUMELOCK CEMENTED SHOULDER PROSTHESIS
K111097 · HSD
Fx Solutions
Orthopedic · 203d
Cleared Nov 08, 2011
CALIX PC SPINAL IMPLANT SYSTEM
K112036 · ODP
X-Spine Systems, Inc.
Orthopedic · 113d