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
13993–14016 of 17,766
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jul 09, 1997
HEADLOC CERAMIC HEAD
K971426 · LZO
Ortho Development Corp.
Orthopedic · 83d
Cleared Jul 09, 1997
INTERSEAL ACETABULAR SCREW HOLE PLUG
K971429 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 82d
Cleared Jul 09, 1997
HEADLOC CERAMIC FEMORAL HEADS
K971435 · LZO
Ortho Development Corp.
Orthopedic · 82d
Cleared Jul 09, 1997
OSTEO COMPRESSION HIP SCREW SYSTEM
K971654 · HWC
Osteonics Corp.
Orthopedic · 64d
Cleared Jul 08, 1997
KAR
K961732 · MEH
Landos, Inc.
Orthopedic · 431d
Cleared Jul 08, 1997
DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)
K971342 · HWE
Disk Whisk, Inc.
Orthopedic · 89d
Cleared Jul 08, 1997
KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS
K971550 · JWH
Howmedica Corp.
Orthopedic · 71d
Cleared Jul 03, 1997
NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI
K970300 · LPH
Intermedics Orthopedics
Orthopedic · 160d
Cleared Jun 27, 1997
ZIRCONIA CERAMIC FEMORAL HEADS WITH FOUNDATION FORGED, TEXTURED AND POROUS...
K965002 · LZO
Encore Orthopedics, Inc.
Orthopedic · 193d
Cleared Jun 27, 1997
ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM
K971282 · MBI
Wrightmedicaltechnologyinc
Orthopedic · 81d
Cleared Jun 27, 1997
LIMITED REUSE ENDOSCOPIC BLADES
K971676 · HRX
Smith & Nephew, Inc.
Orthopedic · 51d
Cleared Jun 27, 1997
J-FX CERCLAGE SYSTEM
K971682 · LRN
Johnson & Johnson Professionals, Inc.
Orthopedic · 52d
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