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
10873–10896 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Aug 16, 2005
TSRH SPINAL SYSTEM
K052054 · NKB
Medtronic Sofamor Danek
Orthopedic · 18d
Cleared Aug 16, 2005
NUBIC SPINAL IMPLANT
K052096 · MQP
Signus Medical, LLC
Orthopedic · 13d
Cleared Aug 15, 2005
U2 ACETABULAR COMPONENT
K050262 · LWJ
United Orthopedic Corp.
Orthopedic · 192d
Cleared Aug 15, 2005
STERLING CANCELLOUS CHIPS
K051615 · MQV
Regeneration Technologies, Inc.
Orthopedic · 59d
Cleared Aug 12, 2005
JOIMAX ENDOSCOPE/MULTISCOPE, THESSYS FORAMINOSCOPE/MULTISCOPE, THESSYS...
K051827 · HRX
Joimax GmbH
Orthopedic · 37d
Cleared Aug 10, 2005
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
K051479 · KRO
Biomet Manufacturing, Inc.
Orthopedic · 68d
Cleared Aug 10, 2005
SBI K-WIRES
K051605 · HTY
Small Bone Innovations, LLC
Orthopedic · 55d
Cleared Aug 10, 2005
CHARLOTTE COMPRESSION PLATE
K051908 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 27d
Cleared Aug 10, 2005
PILONPLATE WITH ANGULAR STABILITY
K052011 · HRS
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 16d
Cleared Aug 08, 2005
MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005
K050655 · HRS
Kapp Surgical Instrument, Inc.
Orthopedic · 147d
Cleared Aug 08, 2005
MONDEAL CONTOUR HO SYSTEM
K050657 · HRS
Kapp Surgical Instrument, Inc.
Orthopedic · 147d
Cleared Aug 05, 2005
DEPUY ASR MODULAR ACETABULAR CUP SYSTEM
K040627 · KWA
DePuy Orthopaedics, Inc.
Orthopedic · 514d
Cleared Aug 05, 2005
COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM
K043547 · KWA
Biomet, Inc.
Orthopedic · 225d
Cleared Aug 05, 2005
EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE
K051385 · KWI
Biomet, Inc.
Orthopedic · 70d
Cleared Aug 05, 2005
AVL HINGE KNEE SYSTEM
K051570 · KRO
Biomet, Inc.
Orthopedic · 52d
Cleared Aug 05, 2005
CHARLOTTE SMALL MTP FUSION PLATE
K051884 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 24d
Cleared Aug 05, 2005
4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
K051949 · MRW
Triage Medical, Inc.
Orthopedic · 21d
Cleared Aug 05, 2005
MODEL 3000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K051983 · MAI
Axya Medical, Inc.
Orthopedic · 14d
Cleared Aug 05, 2005
GII QUICKANCHOR PLUS WITH ORTHOCORD SUTURE
K051989 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 14d
Cleared Aug 05, 2005
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K052037 · KTT
Howmedica Osteonics Corp.
Orthopedic · 8d
Cleared Aug 04, 2005
INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000
K051362 · MAI
Inion OY
Orthopedic · 71d
Cleared Aug 04, 2005
COBALT BONE CEMENT
K051496 · LOD
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 04, 2005
OPTIMA SPINAL SYSTEM
K051971 · KWQ
U&I Corp.
Orthopedic · 14d
Cleared Aug 03, 2005
COBALT G HV BONE CEMENT
K051532 · LOD
Biomet, Inc.
Orthopedic · 55d