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
11545–11568 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared May 25, 2004
SIMPLEX X
K032945 · LOD
Stryker Corp.
Orthopedic · 246d
Cleared May 25, 2004
TRIDENT T ACETABULAR SHELLS
K040412 · LPH
Stryker Orthopaedics
Orthopedic · 97d
Cleared May 25, 2004
ARTHROTEK LACTONAIL
K040500 · HTY
Arthrotek, Inc.
Orthopedic · 89d
Cleared May 25, 2004
MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
K040656 · HWC
Smith & Nephew, Inc.
Orthopedic · 74d
Cleared May 25, 2004
TRIGEN ADOLESCENT TAN
K040929 · HSB
Smith & Nephew, Inc.
Orthopedic · 46d
Cleared May 21, 2004
MICROMAX SUTURE ANCHOR
K040475 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared May 21, 2004
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
K041046 · JWH
Biomet, Inc.
Orthopedic · 29d
Cleared May 20, 2004
PROTEX STABILIZATION SYSTEM
K040442 · MNH
Globus Medical, Inc.
Orthopedic · 90d
Cleared May 17, 2004
COONRAD/MORREY ELBOW CEMENT RESTRICTOR
K040389 · JDC
Zimmer, Inc.
Orthopedic · 90d
Cleared May 14, 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
K030941 · PHX
Tornier
Orthopedic · 416d
Cleared May 14, 2004
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
K040017 · KWQ
Aesculap, Inc.
Orthopedic · 129d
Cleared May 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040962 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared May 13, 2004
KLS MARTIN HAND PLATING SYSTEM
K040598 · HRS
KLS-Martin L.P.
Orthopedic · 66d
Cleared May 13, 2004
BIOKNOTLESS RC ANCHOR
K041064 · JDR
Depuy Mitek
Orthopedic · 20d
Cleared May 12, 2004
HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15
K040381 · MQV
Arthrex, Inc.
Orthopedic · 85d
Cleared May 12, 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · LPH
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared May 12, 2004
SKY BONE EXPANDER SYSTEM (SKY SYSTEM)
K040939 · HRX
Disc-O-Tech Medical Technologies, Ltd.
Orthopedic · 30d
Cleared May 10, 2004
CEMEX GENTA BONE CEMENT
K033596 · LOD
Exactech, Inc.
Orthopedic · 178d
Cleared May 10, 2004
ENDOTINE TRANSBLEPH DEVICE
K040740 · HWC
Coapt Systems, Inc.
Orthopedic · 49d
Cleared May 10, 2004
VAPR 3 ELECTROSURGICAL SYSTEM AND VAPR LD AND LP SUCTION ELECTRODES
K041135 · HRX
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 10d
Cleared May 07, 2004
OSTEO ACL SCREW MODEL
K032894 · HWC
Linvatec Biomaterials, Inc.
Orthopedic · 233d
Cleared May 07, 2004
APAPORE BONE GRAFT SUBSTITUTE
K033722 · MQV
Apatech , Ltd.
Orthopedic · 163d
Cleared May 07, 2004
BIOFILL BONE VOID FILLER
K040454 · MQV
Scient'X
Orthopedic · 74d
Cleared May 07, 2004
SYNTHES (USA) 2.4 MM LCP WRIST PLATE
K040588 · HRS
Synthes (Usa)
Orthopedic · 63d