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
9289–9312 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 12, 2009
ASCENSION SILICONE PIP
K082231 · KYJ
Ascension Orthopedics, Inc.
Orthopedic · 158d
Cleared Jan 12, 2009
OPUS MAGNUM2 AND OPUS MAGNUM X KNOTLESS FIXATION DEVICES
K083240 · MBI
Arthrocare Corp.
Orthopedic · 70d
Cleared Jan 09, 2009
XYCOR SPINAL IMPLANT
K082466 · MQP
Vertebration,Inc
Orthopedic · 135d
Cleared Jan 09, 2009
REVOLVE STABILIZATION SYSTEM
K083416 · NKB
Globus Medical, Inc.
Orthopedic · 52d
Cleared Jan 07, 2009
PERI-LOC BONE PLATING AND SCREW SYSTEM
K083032 · HRS
Smith & Nephew, Inc.
Orthopedic · 89d
Cleared Jan 02, 2009
THEKEN SPINE VU EPOD AND VU LPOD SYSTEM
K082712 · MAX
Theken Spine, LLC
Orthopedic · 108d
Cleared Dec 30, 2008
ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART
K082999 · MAI
Arthrex, Inc.
Orthopedic · 83d
Cleared Dec 30, 2008
SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES
K083213 · HRS
Synthes (Usa)
Orthopedic · 60d
Cleared Dec 29, 2008
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
K082792 · JDI
Medacta International S.A.
Orthopedic · 97d
Cleared Dec 29, 2008
REJUVENATE MONOLITHIC HIP SYSTEM
K082892 · MEH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 29, 2008
CLYDESDALE SPINAL SYSTEM
K083026 · MAX
Medtronic Sofamor Danek
Orthopedic · 80d
Cleared Dec 24, 2008
MODIFICATION TO:MICROFUSE BONE VOID FILLER
K083232 · MQV
Globus Medical, Inc.
Orthopedic · 51d
Cleared Dec 22, 2008
PHANTOM PLUS CAGE SYSTEM
K082801 · ODP
Us Spine
Orthopedic · 89d
Cleared Dec 22, 2008
ZUMA, MODEL 55-XXXX/56-XXXX
K082926 · OVD
Seaspine, Inc.
Orthopedic · 82d
Cleared Dec 19, 2008
PROXIMAL HUMERUS SCAFFOLD FIXATION SYSTEM (PHSFS)
K081608 · HRS
Toby Orthopaedics, LLC
Orthopedic · 193d
Cleared Dec 19, 2008
RIMCLOSE BONE ANCHOR
K082729 · MBI
Anulex Technologies, Inc.
Orthopedic · 92d
Cleared Dec 18, 2008
REGEN COLLAGEN SCAFFOLD (CS)
K082079 · OLC
Regen Biologics, Inc.
Orthopedic · 148d
Cleared Dec 18, 2008
ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS
K082527 · HRS
Zimmer, Inc.
Orthopedic · 107d
Cleared Dec 18, 2008
DEPUY GLOBAL AP CTA HUMERAL HEAD
K082715 · HSD
DePuy Orthopaedics, Inc.
Orthopedic · 92d
Cleared Dec 18, 2008
MODIFICATION TO T2 RECON NAIL SYSTEM
K083437 · HSB
Howmedica Osteonics Corp.
Orthopedic · 28d
Cleared Dec 17, 2008
ELLIPSE LUMBAR POSTERIOR OSTEOSYNTHESIS SYSTEM
K081165 · MNH
Spineart
Orthopedic · 237d
Cleared Dec 17, 2008
SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES
K082625 · HRS
Synthes (Usa)
Orthopedic · 99d
Cleared Dec 17, 2008
NOVATION 12/14 CEMENTED FEMORAL STEMS
K083392 · LZO
Exactech, Inc.
Orthopedic · 30d
Cleared Dec 16, 2008
UNITED U2 TOTAL KNEE SYSTEM
K082424 · JWH
United Orthopedic Corp.
Orthopedic · 116d