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
13825–13848 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 14, 1998
BIOFIX BIODEGRADABLE THREADED SUTURE ANCHOR
K972783 · MAI
Bionx Implants, Inc.
Orthopedic · 263d
Cleared Apr 14, 1998
UNIVERSITY PLATE ANTERIOR SYSTEM
K980228 · KWQ
Acromed Corp.
Orthopedic · 82d
Cleared Apr 14, 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · HRS
Depuy, Inc.
Orthopedic · 74d
Cleared Apr 14, 1998
BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR
K980370 · KTT
Biomet, Inc.
Orthopedic · 74d
Cleared Apr 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K980447 · MNH
DePuy Orthopaedics, Inc.
Orthopedic · 68d
Cleared Apr 14, 1998
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K980486 · JDI
Implex Corp.
Orthopedic · 64d
Cleared Apr 14, 1998
WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER
K980496 · MNH
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Apr 14, 1998
ARTICUL/EZE FEMORAL HEADS
K980513 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 63d
Cleared Apr 09, 1998
S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD
K980081 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 90d
Cleared Apr 03, 1998
PROFUSION BONE VOID FILLER
K973704 · MQV
Biogeneration
Orthopedic · 186d
Cleared Apr 03, 1998
ACTIVELOCK MODULAR FEMORAL HIP SYSTEM
K980020 · LPH
Metagen, LLC
Orthopedic · 88d
Cleared Apr 03, 1998
BTI HUMERAL INTRAMEDULLARY ROD SYSTEM
K980102 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 81d
Cleared Apr 03, 1998
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K980286 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 67d
Cleared Apr 03, 1998
DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW
K980440 · HWC
Depuy, Inc.
Orthopedic · 58d
Cleared Mar 27, 1998
BIOFIX BIOABSORBABLE SELF-REINFORCED POLY-L-LACTIDE THREADED BROWLIFT SCREW
K972919 · HWC
Bionx Implants, Inc.
Orthopedic · 232d
Cleared Mar 20, 1998
TOWNLEY PEDICLE SCREW PLATING SYSTEM
K970599 · MNI
Danek Medical, Inc.
Orthopedic · 395d
Cleared Mar 20, 1998
BIONX DISTAL RADIUS SCREW
K974876 · MAI
Bionx Implants, Inc.
Orthopedic · 81d
Cleared Mar 18, 1998
SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM
K973687 · MNH
Spinal Concepts, Inc.
Orthopedic · 173d
Cleared Mar 18, 1998
ORTHOFIX EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING
K974186 · JDW
Orthofix Srl
Orthopedic · 131d
Cleared Mar 18, 1998
DEPUY TRI-LOCK HIP STEM
K974740 · LPH
Depuy, Inc.
Orthopedic · 89d
Cleared Mar 18, 1998
AUTO-DRIVE BONE SCREW
K974785 · HWC
Osteomed Corp.
Orthopedic · 86d
Cleared Mar 18, 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · HRS
Synthes (Usa)
Orthopedic · 77d
Cleared Mar 16, 1998
ORION ANTERIOR CERVICAL PLATE SYSTEM
K973854 · KWQ
Sofamor Danek USA,Inc.
Orthopedic · 164d
Cleared Mar 16, 1998
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K974807 · KWL
Osteonics Corp.
Orthopedic · 83d