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
14953–14976 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 15, 1995
APOFIX CERVICAL SPINE FIXATION
K945022 · KWP
Sofamor Co.
Orthopedic · 214d
Cleared May 15, 1995
CROSS PIN SCREW SYSTEM
K946228 · JDW
Depuy, Inc.
Orthopedic · 144d
Cleared May 15, 1995
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
K950010 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 132d
Cleared May 15, 1995
RINGLOC CONSTRAINED LINER
K950202 · KWZ
Biomet, Inc.
Orthopedic · 117d
Cleared May 15, 1995
ARGUS ARTHROSCOPY INSTRUMENT SYSTEM
K950242 · HRX
Argus Medical Co., Inc.
Orthopedic · 115d
Cleared May 12, 1995
DANEK RIGID ARTHROSCOPE
K950501 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 95d
Cleared May 12, 1995
KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP
K950561 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 93d
Cleared May 11, 1995
BIOSTOP G BONE CEMENT RESTRICTOR
K943727 · LZN
Landos, Inc.
Orthopedic · 282d
Cleared May 11, 1995
ETHICON DRILL BIT AND DRILL GUIDE
K944590 · HSZ
Ethicon, Inc.
Orthopedic · 234d
Cleared May 11, 1995
DEPUY DURALOC 100C ACETABULAR CUP
K951674 · LPH
Depuy, Inc.
Orthopedic · 30d
Cleared May 10, 1995
LINVATEC STASYS-PES FIXATION DEVICE
K934321 · HWC
Linvatec Corp.
Orthopedic · 614d
Cleared May 10, 1995
INCLUSIVE ENDOSCOPE
K943356 · HRX
Danek Medical, Inc.
Orthopedic · 302d
Cleared May 10, 1995
ACE SUPRACONDYLAR PLATE
K950618 · HRS
Ace Medical Co.
Orthopedic · 89d
Cleared May 09, 1995
BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS
K946151 · HRX
Depuy, Inc.
Orthopedic · 144d
Cleared May 09, 1995
1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE
K950705 · HRX
Neuro Navigational Corp.
Orthopedic · 83d
Cleared May 05, 1995
ACUTRAK PLUS FIXATION SYSTEM
K944330 · HWC
Acu Med, Inc.
Orthopedic · 241d
Cleared May 05, 1995
VSP (VARIABLE SCREW PLACEMENT)
K944736 · MNH
Acromed Corp.
Orthopedic · 221d
Cleared May 05, 1995
CONSENSUS(TM) ORTHOPEDIC DRILL BIT
K950013 · HWE
U.S. Medical Products, Inc.
Orthopedic · 122d
Cleared May 05, 1995
SMALL FRAGMENT PLATES AND SCREWS
K951302 · JDS
Medpac
Orthopedic · 44d
Cleared May 03, 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · KTT
Depuy, Inc.
Orthopedic · 138d
Cleared May 02, 1995
2.3 MM DISPOSABLE NEUROVIEW ENDOSCOPE
K940483 · HRX
Neuro Navigational Corp.
Orthopedic · 454d
Cleared May 02, 1995
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · JDI
Biomet, Inc.
Orthopedic · 196d
Cleared May 02, 1995
INDEX ACETABULAT COMPONENT
K950761 · JDI
Biomet, Inc.
Orthopedic · 74d
Cleared May 01, 1995
MICRO-ENDO(TM) INSTRUMENTS
K950130 · HRX
Sofamor Danek USA,Inc.
Orthopedic · 109d