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
12721–12744 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 27, 2001
FRONTIER ANTERIOR SCOLIOSIS SYSTEM
K012916 · KWQ
Depuy Acromed, Inc.
Orthopedic · 89d
Cleared Nov 27, 2001
APEX MODULAR ALUMINA FEMORAL HEAD
K012918 · LZO
Apex Surgical, LLC
Orthopedic · 89d
Cleared Nov 26, 2001
C3 ANTERIOR CERVICAL PLATE SYSTEM
K012881 · KWQ
Spine Vision, Inc.
Orthopedic · 90d
Cleared Nov 21, 2001
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214
K013546 · HWC
Bionx Implants, Inc.
Orthopedic · 28d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED
K012817 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX
K012818 · HWC
Triage Medical, Inc.
Orthopedic · 90d
Cleared Nov 20, 2001
RESORBABLE SCREW ANCHOR
K012872 · HWC
Arthrotek, Inc.
Orthopedic · 85d
Cleared Nov 20, 2001
EBI XFIX ACCESS PELVIC FIXATOR
K013540 · KTT
Ebi, L.P.
Orthopedic · 27d
Cleared Nov 16, 2001
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
K011556 · KWQ
Aesculap, Inc.
Orthopedic · 179d
Cleared Nov 16, 2001
DISCOVERY FACET SCREW FIXATION SYSTEM
K012773 · MRW
Depuyacromed
Orthopedic · 88d
Cleared Nov 16, 2001
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
K012776 · JWH
Howmedica Osteonics Corp.
Orthopedic · 88d
Cleared Nov 16, 2001
INTEX SCREW
K012798 · HWC
Biomet, Inc.
Orthopedic · 87d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013440 · MNI
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
ISOLA POLYAXIAL WASHER
K013441 · KWP
Depuyacromed
Orthopedic · 30d
Cleared Nov 16, 2001
ISOBAR SPINAL SYSTEM
K013444 · MNH
Scien'Tx USA, Inc.
Orthopedic · 30d
Cleared Nov 16, 2001
LONG LENGTH DYAX NAIL
K013468 · HSB
Howmedica Osteonics Corp.
Orthopedic · 29d
Cleared Nov 16, 2001
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · KTT
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Nov 16, 2001
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW
K013557 · MBI
Walter Lorenz Surgical, Inc.
Orthopedic · 23d
Cleared Nov 15, 2001
PASS SPINAL SYSTEM
K013431 · MNI
Encore Orthopedics, Inc.
Orthopedic · 30d
Cleared Nov 14, 2001
CONVERGE ACETABULAR SYSTEM
K012739 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
HEALOS BONE GRAFT MATERIAL
K012751 · MQV
Orquest, Inc.
Orthopedic · 90d
Cleared Nov 14, 2001
TRI-FIX SPINAL FIXATION SYSTEM
K013403 · MNI
Endius, Inc.
Orthopedic · 30d
Cleared Nov 14, 2001
TROCHANTERIC DYAX NAIL SYSTEM
K013524 · HSB
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 13, 2001
BSM BONE SUBSTITUTE MATERIAL
K011048 · MQV
DePuy Orthopaedics, Inc.
Orthopedic · 221d