FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Orthopedic ×
17,985 results
13969–13992 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
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
Cleared Mar 16, 1998
EXTERNAL FIXATOR
K974911 · JDW
Avanta Orthopaedics, Inc.
Orthopedic · 75d
Cleared Mar 16, 1998
ACUMED SUTURE ANCHOR
K980103 · MBI
Acu Med, Inc.
Orthopedic · 63d
Cleared Mar 13, 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 185d
Cleared Mar 13, 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706 · KWQ
Aesculap, Inc.
Orthopedic · 87d
Cleared Mar 13, 1998
HOWMEDICA(R) FULLY THREADED SCREWS
K974720 · HSB
Howmedica, Inc.
Orthopedic · 85d
Cleared Mar 13, 1998
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS...
K974749 · MNH
Cross Medical Products, Inc.
Orthopedic · 84d
Cleared Mar 12, 1998
BTI LARGE (7.0MM) CANNULATED TRANSFIXING SCREWS
K974756 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 83d
Cleared Mar 10, 1998
PLAQUAGRAFE, AGRAFE P4V
K974603 · HRS
Atlas Technology
Orthopedic · 90d
Cleared Mar 10, 1998
AURORA TITANIUM SPINAL ROD SYSTEM
K974734 · MNH
United States Surgical, A Division of...
Orthopedic · 82d