FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
12001–12024 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 29, 2003
S2 NAIL SYSTEM
K032579 · HSB
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 28, 2003
INION OTPS BIODEGRADABLE PIN
K031712 · HTY
Inion , Ltd.
Orthopedic · 87d
Cleared Aug 25, 2003
MITEK MICRO QUICKANCHOR
K032078 · NOV
Mitek Worldwide
Orthopedic · 49d
Cleared Aug 22, 2003
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · HWC
Osteomed LP
Orthopedic · 133d
Cleared Aug 22, 2003
TRAXIS CEMENT RESTRICTOR
K031318 · JDK
Spinal Concepts, Inc.
Orthopedic · 119d
Cleared Aug 22, 2003
STRYKER SPINE OASYS BONE SCREW
K031657 · MRW
Howmedica Osteonics Corp.
Orthopedic · 86d
Cleared Aug 21, 2003
COLUMBUS (PS)
K030367 · JWH
Aesculap, Inc.
Orthopedic · 198d
Cleared Aug 21, 2003
SYNTHES (USA) CALVICLE HOOK PLATE
K031677 · HRS
Synthes (Usa)
Orthopedic · 83d
Cleared Aug 21, 2003
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
K032295 · JWH
Smith & Nephew, Inc.
Orthopedic · 27d
Cleared Aug 21, 2003
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K032396 · JDI
Biomet, Inc.
Orthopedic · 17d
Cleared Aug 20, 2003
MODIFICATION ORIA SPINAL SYSTEM
K023884 · KWP
Ortho Tec, LLC
Orthopedic · 272d
Cleared Aug 13, 2003
MODIFICATION TO CERASORB ORTHO
K031651 · MQV
Curasan AG
Orthopedic · 77d
Cleared Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 188d
Cleared Aug 12, 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · HSB
Zimmer, Inc.
Orthopedic · 11d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · LPH
Biomet, Inc.
Orthopedic · 217d
Cleared Aug 11, 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Aug 11, 2003
CD HORIZON SPINAL SYSTEM
K032265 · KWQ
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Aug 08, 2003
HBS HEADLESS BONE SCREW
K030302 · HWC
Schoening & Assoc., Inc.
Orthopedic · 191d
Cleared Aug 08, 2003
OPUS SPINAL SYSTEM
K030369 · NKB
Howmedica Osteonics Corp.
Orthopedic · 185d
Cleared Aug 08, 2003
SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE
K031428 · LXT
Synthes (Usa)
Orthopedic · 94d
Cleared Aug 08, 2003
REFLEX ANTERIOR CERVICAL PLATE SYSTEM
K031702 · KWQ
Howmedica Osteonics
Orthopedic · 67d
Cleared Aug 08, 2003
OMNIFIT HFX HIP STEM SERIES
K031744 · JDI
Howmedica Osteonics Corp.
Orthopedic · 64d
Cleared Aug 08, 2003
INTERPORE CROSS CEMENT RESTRICTOR
K032095 · JDK
Interpore Cross Intl.
Orthopedic · 31d
Cleared Aug 08, 2003
DEPUY ACE VERSANAIL TIBIAL NAIL
K032097 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 31d