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
10537–10560 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 17, 2006
ACTIVE UNICOMPARTMENTAL KNEE SYSTEM
K060412 · HRY
Australian Surgical Design & Manufacture
Orthopedic · 90d
Cleared May 17, 2006
TTC PLATE
K060473 · HRS
New Deal, S.A.
Orthopedic · 83d
Cleared May 17, 2006
LAPIDUS PLATE
K060476 · HRS
New Deal, S.A.
Orthopedic · 83d
Cleared May 15, 2006
PYRENEES CERVICAL PLATE SYSTEM
K060442 · KWQ
K2m, LLC
Orthopedic · 83d
Cleared May 12, 2006
ZIMMER M/L TAPER HIP PROSTHESIS
K060040 · LPH
Zimmer, Inc.
Orthopedic · 126d
Cleared May 12, 2006
POLYAX LOCKED PLATING SYSTEM
K060969 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 35d
Cleared May 11, 2006
MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW,...
K060198 · HRX
Linvatec Corp.
Orthopedic · 105d
Cleared May 11, 2006
LIFE SPINE CEMENT RESTRICTOR
K060247 · JDK
Life Spine
Orthopedic · 100d
Cleared May 10, 2006
HIPSTAR FEMORAL STEM
K051223 · LZO
Stryker Orthopaedics
Orthopedic · 363d
Cleared May 10, 2006
PROFEMUR TL HIP STEM
K060358 · KWA
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared May 10, 2006
NEXA CARPO METACARPAL IMPLANT
K060386 · KYI
Nexa Orthopedics, Inc.
Orthopedic · 85d
Cleared May 10, 2006
XPAND RADIOLUCENT CORPECTOMY SPACER
K060665 · MQP
Globus Medical, Inc.
Orthopedic · 57d
Cleared May 05, 2006
ASCENSION PYROSPHERE CMC/TMT
K060560 · KWD
Ascension Orthopedics, Inc.
Orthopedic · 64d
Cleared May 04, 2006
SPIRALOK ANCHOR
K060271 · HWC
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 92d
Cleared May 04, 2006
RC LOOP /DUAL ORTHOCORD SUTURE,RC LOOP W/ETHIBOND SUTURE,RC LOOP W/PANACRYL...
K060553 · JDR
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 64d
Cleared May 03, 2006
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
K052639 · JDI
Biomet Manufacturing, Inc.
Orthopedic · 219d
Cleared May 03, 2006
LEGION COBALT CHROME REVISION KNEE SYSTEM
K060742 · JWH
Smith & Nephew, Inc.
Orthopedic · 44d
Cleared May 01, 2006
NOVABONE PUTTY - BIOACTIVE SYNTHETIC GRAFT
K060728 · MQV
Novabone Products, LLC
Orthopedic · 45d
Cleared Apr 28, 2006
POROUS TITANIUM ACETABULAR SHELLS
K052996 · LPH
Biomet Manufacturing Corp
Orthopedic · 185d
Cleared Apr 28, 2006
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
K060370 · JWH
Zimmer, Inc.
Orthopedic · 74d
Cleared Apr 28, 2006
ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS
K060577 · LZO
Ortho Development Corp.
Orthopedic · 53d
Cleared Apr 28, 2006
CONSENSUS ACETABULAR SHELL SYSTEM
K060635 · LPH
Hayes Medical, Inc.
Orthopedic · 49d
Cleared Apr 28, 2006
DSI PINS AND WIRES
K060654 · HTY
Delta Surgical Instruments, Inc.
Orthopedic · 46d
Cleared Apr 28, 2006
MULTIDIRECTIONAL THREADED PEG
K060864 · LXT
Hand Innovations, LLC
Orthopedic · 29d