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
10921–10944 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 19, 2005
MARROW PLUS (M+)
K051695 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 26d
Cleared Jul 19, 2005
PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY
K051735 · HRS
Smith & Nephew, Inc.
Orthopedic · 21d
Cleared Jul 19, 2005
MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE
K051737 · LZO
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 19, 2005
SECUR-FIT MAX AND PLUS MAX HIP STEMS
K051738 · LZO
Howmedica Osteonics Corp.
Orthopedic · 21d
Cleared Jul 15, 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406 · NDN
Depuy Spine, Inc.
Orthopedic · 217d
Cleared Jul 14, 2005
TORNIER ELBOW PROSTHESIS
K050848 · JDB
Tornier
Orthopedic · 101d
Cleared Jul 13, 2005
SYNTHES (USA) LOW-PROFILE WRIST FIXATOR
K051049 · KTT
Synthes (Usa)
Orthopedic · 79d
Cleared Jul 13, 2005
TRIATHLON KNEE SYSTEM
K051146 · JWH
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Jul 13, 2005
SEMIAL SPINAL IMPLANT
K051659 · MQP
Signus Medizintechnik GmbH
Orthopedic · 21d
Cleared Jul 13, 2005
T-PLATE ANTERIOR FIXATION SYSTEM
K051764 · KWQ
Esm Technologies
Orthopedic · 13d
Cleared Jul 12, 2005
BIOLOX DELTA CERAMIC FEMORAL HEADS
K051588 · LZO
Howmedica Osteonics Corp.
Orthopedic · 27d
Cleared Jul 12, 2005
MALIBU SPINAL SYSTEM
K051663 · NKB
Seaspine, Inc.
Orthopedic · 20d
Cleared Jul 11, 2005
SOLCO 4CIS GENERAL PLATE SYSTEM
K051155 · HRS
Solco Biomedical Co., Ltd.
Orthopedic · 68d
Cleared Jul 11, 2005
ROI FUSION RODS & PLATES
K051309 · HWC
Reiley Orthopaedics, Inc.
Orthopedic · 53d
Cleared Jul 11, 2005
HUMERAL HEAD PLATE WITH ANGULAR STABILITY
K051412 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 41d
Cleared Jul 07, 2005
QUANTUM VERTEBRAL BODY REPLACEMENT
K050449 · MQP
Quantum Orthopedics, Inc.
Orthopedic · 135d
Cleared Jul 07, 2005
CONNEXUS
K050690 · MQV
Isotis Orthobiologics, Inc.
Orthopedic · 112d
Cleared Jul 07, 2005
PALACOS LV+G
K050854 · LOD
Heraeus Kulzer,GmbH
Orthopedic · 94d
Cleared Jul 07, 2005
PALAMED G
K050855 · LOD
Heraeus Kulzer,GmbH
Orthopedic · 94d
Cleared Jul 07, 2005
PIVOT BIPOLAR FEMORAL HEAD
K050966 · KWY
Ortho Development Corp.
Orthopedic · 80d
Cleared Jul 07, 2005
PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES
K051098 · HWC
Zimmer, Inc.
Orthopedic · 69d
Cleared Jul 07, 2005
MERETE TWISTCUT SNAP-OFF BONE SCREW
K051323 · HWC
Merete Medical GmbH
Orthopedic · 48d
Cleared Jul 07, 2005
T2 RECON NAIL SYSTEM
K051624 · HSB
Howmedica Osteonics Corp.
Orthopedic · 17d
Cleared Jul 06, 2005
EXPEDIUM SPINE SYSTEM
K051024 · NKB
Depuy Spine, Inc.
Orthopedic · 75d