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
14089–14112 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jun 27, 1997
OSTEO SMALL AND MINI BONE SCREWS
K971778 · HWC
Osteonics Corp.
Orthopedic · 44d
Cleared Jun 25, 1997
AESUCLAP SOCON SPINAL SYSTEM
K970285 · MNH
Aesculap, Inc.
Orthopedic · 152d
Cleared Jun 25, 1997
BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT
K971139 · MBI
Boston Scientific Corp
Orthopedic · 89d
Cleared Jun 25, 1997
MULTITAK SS SUTURE SYSTEM
K971144 · MBI
Bonutti Research
Orthopedic · 89d
Cleared Jun 24, 1997
ORTHOTEC K-CAP SYSTEM
K971453 · HTY
Orthotech
Orthopedic · 64d
Cleared Jun 23, 1997
ARTHROSCOPE
K971083 · HRX
Electro-Biology, Inc.
Orthopedic · 90d
Cleared Jun 20, 1997
PRELOADED SOFT TISSUE ANCHOR
K963932 · MBI
Linvatec Corp.
Orthopedic · 262d
Cleared Jun 20, 1997
FUTURA BIOMEDICAL METAL HEMI TOE IMPLANT
K971047 · KWD
Nexa Orthopedics, Inc.
Orthopedic · 91d
Cleared Jun 19, 1997
IMPLEX A-240 HEP ACETABULAR CUP SYSTEM
K964509 · LPH
Implex Corp.
Orthopedic · 223d
Cleared Jun 19, 1997
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650 · LPH
Depuy, Inc.
Orthopedic · 211d
Cleared Jun 18, 1997
LSF TRIAD TOTAL HIP SYSTEM
K971020 · LPH
Osteoimplant Technology, Inc.
Orthopedic · 90d
Cleared Jun 18, 1997
UNIVERSAL DRIVE SYSTEM
K971059 · HRX
Linvatec Corp.
Orthopedic · 86d
Cleared Jun 18, 1997
SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
K971289 · KWP
Osteotech, Inc.
Orthopedic · 72d
Cleared Jun 13, 1997
VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS
K971253 · HRX
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE
K963612 · JDI
Howmedica Corp.
Orthopedic · 274d
Cleared Jun 11, 1997
DURATION STABILIZED UHMWPE KNEE COMPONENTS
K965173 · JWH
Howmedica Corp.
Orthopedic · 169d
Cleared Jun 11, 1997
ACROMED ANTERIOR CERVICAL STABILIZATION SYSTEM
K970955 · KWQ
Acromed Corp.
Orthopedic · 86d
Cleared Jun 11, 1997
KANEDA SR ANTERIOR SPINAL SYSTEM
K971248 · KWQ
Acromed Corp.
Orthopedic · 69d
Cleared Jun 09, 1997
BIO-ANCHOR
K964805 · MAI
Linvatec Corp.
Orthopedic · 192d
Cleared Jun 09, 1997
MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM
K970896 · MAI
Ethicon, Inc.
Orthopedic · 90d
Cleared Jun 09, 1997
DEPUY LOW PROFILE BONE SCREW
K970929 · HWC
Depuy, Inc.
Orthopedic · 88d
Cleared Jun 05, 1997
22.2/+4MM CO CR & ZIRCONIA FEMORAL HEAD
K970846 · LZO
Landos, Inc.
Orthopedic · 90d
Cleared Jun 05, 1997
MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM
K971135 · HSB
Wrightmedicaltechnologyinc
Orthopedic · 70d
Cleared Jun 05, 1997
TRAUMA-FIX EXTERNAL FIXATOR
K971272 · KTW
Trend Medical, Inc.
Orthopedic · 62d