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
11161–11184 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Mar 07, 2005
MODIFICATION TO: INION OTPS BIODEGRADABLE PIN
K050275 · HTY
Inion , Ltd.
Orthopedic · 28d
Cleared Mar 04, 2005
HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM
K050048 · KTT
Howmedica Osteonics Corp.
Orthopedic · 53d
Cleared Mar 04, 2005
SYNTHES (USA) LCP MODULAR FOOT PLATES
K050110 · HRS
Synthes (Usa)
Orthopedic · 45d
Cleared Mar 02, 2005
STRYKER SPINE TRIO PS
K043180 · MNH
Stryker Spine
Orthopedic · 105d
Cleared Mar 02, 2005
THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER
K050227 · MBI
Linvatec Corp.
Orthopedic · 29d
Cleared Feb 25, 2005
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K050041 · JDQ
Synthes (Usa)
Orthopedic · 49d
Cleared Feb 24, 2005
EPIPHYSIS SCREW
K043410 · HWC
I.T.S. Implantat-Technologie-Systeme...
Orthopedic · 76d
Cleared Feb 18, 2005
INTERGRO DBM
K031399 · MQV
Interpore Cross Intl.
Orthopedic · 655d
Cleared Feb 18, 2005
STANSION MATRIX
K042600 · MQP
Spineworks, LLC
Orthopedic · 148d
Cleared Feb 18, 2005
INION OTPS BIODEGRADABLE MINI PLATING SYSTEM
K043142 · HWC
Inion , Ltd.
Orthopedic · 95d
Cleared Feb 18, 2005
BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B
K043145 · HTN
Arthrex, Inc.
Orthopedic · 95d
Cleared Feb 18, 2005
BLAKSTONE LAMINOPLASTY FIXATION SYSTEM
K043338 · NQW
Blackstone Medical, Inc.
Orthopedic · 77d
Cleared Feb 18, 2005
4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N
K043351 · MRW
Triage Medical, Inc.
Orthopedic · 74d
Cleared Feb 18, 2005
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
K043440 · JWH
Smith & Nephew, Inc.
Orthopedic · 66d
Cleared Feb 18, 2005
ROC LUMBAR PLATING SYSTEM
K050078 · MNH
Alphatec/Nexmed
Orthopedic · 36d
Cleared Feb 18, 2005
MODIFICATION TO TSRH SPINAL SYSTEM
K050282 · NKB
Medtronic Sofamor Danek
Orthopedic · 11d
Cleared Feb 17, 2005
MODIFICATION TO GLOBAL SPINAL FIXATION SYSTEM
K042928 · MNH
U&I Corp.
Orthopedic · 118d
Cleared Feb 17, 2005
BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS
K043100 · MBF
Biomet, Inc.
Orthopedic · 100d
Cleared Feb 17, 2005
RESOFIX BIOABSORBABLE EXPANSION BOLT
K043411 · HTN
Resofix, Inc.
Orthopedic · 69d
Cleared Feb 17, 2005
MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM
K050117 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d
Cleared Feb 16, 2005
TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS
K043248 · HTN
Arthrex, Inc.
Orthopedic · 85d
Cleared Feb 16, 2005
MODIFICATION TO: HEALOS BONE GRAFT MATERIAL
K043308 · MQV
Depuy Spine, Inc.
Orthopedic · 77d
Cleared Feb 16, 2005
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
K043374 · MBH
Howmedica Osteonics Corp.
Orthopedic · 70d
Cleared Feb 16, 2005
OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC
K043421 · MQV
Regeneration Technologies, Inc.
Orthopedic · 65d