FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Orthopedic ×
17,850 results
17065–17088 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 10, 1986
MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K860133 · HRY
Depuy, Inc.
Orthopedic · 55d
Cleared Mar 10, 1986
ACE MULTIPLE PIN PLATE
K860591 · HRS
Buckman Co., Inc.
Orthopedic · 19d
Cleared Mar 07, 1986
ISOSTATION KNEE MACHINE (K-100)
K854621
Isotechnologies, Inc.
Orthopedic · 109d
Cleared Mar 07, 1986
ACE UNILATERAL FIXATOR
K860590 · HTY
Buckman Co., Inc.
Orthopedic · 16d
Cleared Mar 05, 1986
MONOFIXATEUR
K854336 · HWC
Ortopedia GmbH
Orthopedic · 128d
Cleared Mar 05, 1986
LINK METAL-BACKED ACETABULAR CUPS
K854935 · JDL
Link America, Inc.
Orthopedic · 85d
Cleared Mar 05, 1986
MARKOPTIC IMPROVED ARTHROSCOPE
K860607 · HRX
Markoptic
Orthopedic · 14d
Cleared Mar 04, 1986
3M ARTHROSCOPIC SURGICAL SYSTEM
K855216 · HWE
3M Company
Orthopedic · 64d
Cleared Mar 03, 1986
AOT EXTERNAL COMPRESS DEVICE
K854241 · HWN
Advanced Ortho-Technology, Inc.
Orthopedic · 133d
Cleared Feb 27, 1986
BIO-FIT HIP SYSTEM
K854791 · KWL
Richards Medical Co., Inc.
Orthopedic · 90d
Cleared Feb 27, 1986
HOWMEDICA BIPOLAR PROSTHESIS
K855231 · KWY
Howmedica Corp.
Orthopedic · 59d
Cleared Feb 21, 1986
HOFMANN KNEE
K853991 · JWH
Intermedics Orthopedics
Orthopedic · 147d
Cleared Feb 21, 1986
FLEX-I-GRASP
K854889 · HRX
Euro-Med Intl.
Orthopedic · 77d
Cleared Feb 20, 1986
OMKNEE SYSTEM, POROUS COATED
K854943
Orthomet, Inc.
Orthopedic · 72d
Cleared Feb 19, 1986
REESE ARTHRODESIS SCREW
K860323 · HWC
Osteotomy Guide Co.
Orthopedic · 21d
Cleared Feb 18, 1986
FREEMAN-SAMUELSON MARK II PRESS-FIT TOTAL KNEE REP
K853730 · MBV
Protek, Inc.
Orthopedic · 165d
Cleared Feb 18, 1986
OMKNEE SYSTEM
K854883 · JWH
Orthomet, Inc.
Orthopedic · 74d
Cleared Feb 18, 1986
THARIES FIBER
K855148
Zimmer, Inc.
Orthopedic · 54d
Cleared Feb 12, 1986
FENLIN TOTAL SHOULDER
K852137
Zimmer, Inc.
Orthopedic · 272d
Cleared Feb 12, 1986
FEMOROTIBIAL MEDULLARY NAIL
K853250 · HSB
Zimmer, Inc.
Orthopedic · 195d
Cleared Feb 11, 1986
MARTIN LAMINAR OSTEOSYNTHESIS SYSTEM
K854770 · KWP
Advanced Biosearch Assn.
Orthopedic · 76d
Cleared Feb 11, 1986
INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM
K854987 · HWE
Richard Wolf Medical Instruments Corp.
Orthopedic · 61d
Cleared Feb 11, 1986
KMW HIP PROSTHESIS POROUS COATED
K855123
Kirkschner Medical Corp.
Orthopedic · 50d
Cleared Feb 11, 1986
FEMORAL HEMI-HIP PROSTHESES
K855228 · KWL
Orthopaedic Device Corp.
Orthopedic · 43d