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
9409–9432 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 02, 2008
NUVASIVE COROENT SYSTEM
K081611 · ODP
Nuvasive, Inc.
Orthopedic · 115d
Cleared Oct 02, 2008
ATLAS SPINE SPACER
K081880 · ODP
Atlas Spine, Inc.
Orthopedic · 92d
Cleared Oct 01, 2008
OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500
K081893 · HWC
Arthrocare Corp.
Orthopedic · 90d
Cleared Sep 30, 2008
ENCORE SHOULDER REVISION GLENOID
K081448 · MBF
Encore Medical, L.P.
Orthopedic · 130d
Cleared Sep 26, 2008
ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY...
K081860 · LZO
Zimmer, Inc.
Orthopedic · 87d
Cleared Sep 26, 2008
SEEPLATE CERVICAL PLATE SYSTEM
K082037 · KWQ
Amedica Corp.
Orthopedic · 71d
Cleared Sep 26, 2008
UNITED U2 PATELLA
K082469 · JWH
United Orthopedic Corp.
Orthopedic · 30d
Cleared Sep 24, 2008
ACCELL TBM-R
K081817 · MBP
Isotis Orthobiologics, Inc.
Orthopedic · 90d
Cleared Sep 24, 2008
MODIFICATION TO PREFERENCE PEDICLE SCREW SYSTEM
K081883 · MNH
Us Spine
Orthopedic · 84d
Cleared Sep 24, 2008
NUVASIVE LATERAL PLATE SYSTEM
K082070 · KWQ
Nuvasive, Inc.
Orthopedic · 64d
Cleared Sep 23, 2008
4CIS SOLAR AND APOLLON SPINE SYSTEMS
K082453 · MNH
Solco Biomedical Co., Ltd.
Orthopedic · 29d
Cleared Sep 22, 2008
UNIVATION UNICONDYLAR KNEE SYSTEM
K081293 · HRY
Aesculap Implant Systems, Inc.
Orthopedic · 138d
Cleared Sep 19, 2008
NOVEL CERVICAL SPINAL SPACER SYSTEM
K081730 · ODP
Alphatec Spine, Inc.
Orthopedic · 93d
Cleared Sep 17, 2008
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS
K082516 · HWC
Smith & Nephew, Inc.
Orthopedic · 15d
Cleared Sep 16, 2008
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM
K082270 · MAX
Vertiflex, Inc.
Orthopedic · 36d
Cleared Sep 15, 2008
BLACKSTONE PEDICLE SCREW SYSTEM
K081684 · NKB
Blackstone Medical, Inc.
Orthopedic · 90d
Cleared Sep 12, 2008
MODIFICATION TO CAPSTONE SPINAL SYSTEM
K082342 · MAX
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 11, 2008
LUCENT MAGNUM+
K081711 · OVD
Spinal Elements, Inc.
Orthopedic · 86d
Cleared Sep 11, 2008
ACTIFUSE FLOW BONE GRAFT SUBSTITUTE
K082073 · MQV
Apatech , Ltd.
Orthopedic · 50d
Cleared Sep 10, 2008
EXPEDIUM SPINE SYSTEM
K081898 · NKB
Depuy Spine, Inc.
Orthopedic · 69d
Cleared Sep 10, 2008
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM
K082273 · KWQ
Depuy Spine, Inc.
Orthopedic · 30d
Cleared Sep 09, 2008
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 116d
Cleared Sep 09, 2008
METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD
K082146 · LWJ
Aesculap Implant Systems, Inc.
Orthopedic · 41d
Cleared Sep 09, 2008
SURGVIEW INTEGRATED VISUALIZATION SYSTEM
K082293 · HRX
Biovision Technologies, LLC
Orthopedic · 28d