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
10465–10488 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 07, 2006
TRIDENT CONSTRAINED ACETABULAR INSERT
K061654 · KWZ
Howmedica Osteonics Corp.
Orthopedic · 24d
Cleared Jul 06, 2006
BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
K053213 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 232d
Cleared Jul 06, 2006
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
K060569 · JWH
Ortho Development Corp.
Orthopedic · 125d
Cleared Jul 06, 2006
ACTIVAPIN
K061164 · HTY
Bioretec, Ltd.
Orthopedic · 71d
Cleared Jul 06, 2006
ALLOFIX ANCHOR, 5.0 MM ANCHOR
K061498 · JDW
Musculoskeletal Transplant Foundation
Orthopedic · 36d
Cleared Jul 06, 2006
SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS
K061569 · NPJ
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Jul 05, 2006
AXYALOOP NONABSORBABLE BONE ANCHOR
K060970 · JDR
Axya Medical, Inc.
Orthopedic · 89d
Cleared Jul 05, 2006
LIGAFIX INTERFERENCE SCREW
K061262 · HWC
Sciences For Bio Materials
Orthopedic · 61d
Cleared Jul 03, 2006
MYKRES SPINAL SYSTEM
K051704 · MNI
Showa Ika Kohgyo Co., Ltd.
Orthopedic · 374d
Cleared Jul 03, 2006
STAXX FX SYSTEM
K053336 · NDN
Spine Wave, Inc.
Orthopedic · 214d
Cleared Jul 03, 2006
OSTEO-LINK BONE VOID FILLER PELLETS
K060809 · MQV
Promed Advance Technology Co., Ltd.
Orthopedic · 101d
Cleared Jul 03, 2006
DYNASTY ACETABULAR SHELL
K061547 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Jul 03, 2006
MODIFICATION TO QUANTUM VERTEBRAL BODY REPLACEMENT SYSTEM
K061576 · MQP
Quantum Orthopedics, Inc.
Orthopedic · 26d
Cleared Jul 03, 2006
MODIFICATION TO CD HORIZON SYSTEM
K061592 · NKB
Medtronic Sofamor Danek, Inc.
Orthopedic · 25d
Cleared Jul 03, 2006
LARGE UNI-CLIP STAPLE
K061594 · JDR
New Deal, S.A.
Orthopedic · 25d
Cleared Jun 30, 2006
OPTERYX ANTERIOR CERVICAL PLATE SYSTEM
K061147 · KWQ
Innovasis, Inc.
Orthopedic · 66d
Cleared Jun 29, 2006
CALCANEAL TRAUMA SYSTEM
K061400 · HRS
Orthohelix Surgical Designs, Inc.
Orthopedic · 41d
Cleared Jun 28, 2006
DEPUY GLOBAL AP SHOULDER SYSTEM
K060874 · KWS
DePuy Orthopaedics, Inc.
Orthopedic · 90d
Cleared Jun 23, 2006
VIPER SPINE SYSTEM
K061520 · NKB
Depuy Spine, Inc.
Orthopedic · 21d
Cleared Jun 23, 2006
EBI ARRAY SPINAL SYSTEM
K061563 · NKB
Ebi, L.P.
Orthopedic · 18d
Cleared Jun 22, 2006
4CIS VANE SPINE SYSTEM
K060702 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 98d
Cleared Jun 21, 2006
CONFIDENCE HIGH VISCOSITY BONE CEMENT
K060300 · NDN
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 135d
Cleared Jun 20, 2006
MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597,...
K061089 · KYI
Biopro, Inc.
Orthopedic · 63d
Cleared Jun 19, 2006
US SPINE FACET FIXATION SYSTEM
K061041 · MRW
Us Spine
Orthopedic · 66d