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
9049–9072 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 15, 2009
TALOS INTERVERTEBRAL BODY FUSION DEVICE
K090707 · MAX
Meditech Advisors, LLC
Orthopedic · 120d
Cleared Jul 15, 2009
TRIMED STERILE PRODUCT
K091156 · HRS
TriMed, Inc.
Orthopedic · 85d
Cleared Jul 15, 2009
CD HORIZON SPINAL SYSTEM
K091442 · NKB
Medtronic Sofamor Danek
Orthopedic · 61d
Cleared Jul 14, 2009
VALOR ANKLE FUSION NAIL SYSTEM
K090857 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 106d
Cleared Jul 14, 2009
ZYFUSE FACET FIXATION SYSTEM
K090952 · MRW
Globus Medical, Inc.
Orthopedic · 102d
Cleared Jul 14, 2009
5.5 POLARIS SPINAL SYSTEM
K091067 · NKB
Biomet Spine
Orthopedic · 91d
Cleared Jul 14, 2009
LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
K091088 · ODP
Ldr Spine USA
Orthopedic · 90d
Cleared Jul 14, 2009
DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP
K091751 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 28d
Cleared Jul 13, 2009
APTUS FOOT SYSTEM
K091479 · HRS
Medartis AG
Orthopedic · 55d
Cleared Jul 10, 2009
NEWDEAL HALLU LOCK PLATE SYSTEM
K083154 · HRS
Newdeal Sas
Orthopedic · 259d
Cleared Jul 10, 2009
GMK TOTAL KNEE SYSTEM
K090988 · JWH
Medacta International S.A.
Orthopedic · 94d
Cleared Jul 10, 2009
SYNTHES ORACLE PLATE
K091159 · KWQ
Synthes Spine
Orthopedic · 80d
Cleared Jul 10, 2009
SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
K091689 · KWP
Synthes (Usa)
Orthopedic · 30d
Cleared Jul 09, 2009
SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM
K091044 · KWQ
Spinal USA
Orthopedic · 87d
Cleared Jul 09, 2009
DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
K091219 · NKB
Allez Spine, LLC
Orthopedic · 73d
Cleared Jul 08, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K091189 · MNI
Alphatec Spine, Inc.
Orthopedic · 76d
Cleared Jul 07, 2009
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
K090779 · MNI
Alphatec Spine, Inc.
Orthopedic · 106d
Cleared Jul 07, 2009
MODIFICATION TO:LATARJET CORTICAL SCREW SET, MODELS 523JT, 523J (36-48MM)
K091694 · HWC
Tag Medical Products
Orthopedic · 27d
Cleared Jul 02, 2009
MILI (MINIMALLY INVASIVE LUMBAR IMPLANT) SYSTEM
K083004 · NKB
Aesculap Implant Systems, Inc.
Orthopedic · 267d
Cleared Jul 02, 2009
OSTEOMED HAND PLATE AND SCREW FIXATION SYSTEM
K090522 · HRS
Osteomed LP
Orthopedic · 126d
Cleared Jul 02, 2009
CALCANEAL FRACTURE PLATE SYSTEM
K090582 · HRS
Tornier, Inc.
Orthopedic · 120d
Cleared Jul 02, 2009
MODIFICATION TO: NUVASIVE SPHERX SYSTEM
K090981 · NKB
Nuvasive, Inc.
Orthopedic · 86d
Cleared Jul 01, 2009
INFLATABLE BONE TAMP
K090211 · NDN
Cardinal Health, Inc.
Orthopedic · 154d
Cleared Jul 01, 2009
POLARIS SPINAL SYSTEM
K090523 · NKB
Ebi, L.P.
Orthopedic · 125d