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
11353–11376 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 07, 2004
SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION)
K042135 · HSB
Synthes (Usa)
Orthopedic · 59d
Cleared Oct 07, 2004
EXCELLA-M SPINAL SYSTEM
K042143 · KWP
Innovasis, Inc.
Orthopedic · 59d
Cleared Oct 07, 2004
NOVEL VBR SPINAL SYSTEM
K042201 · MQP
Alphatec/Nexmed
Orthopedic · 55d
Cleared Oct 07, 2004
TITANIUM TELEGRAPH HUMERAL NAIL
K042332 · HSB
Fournitures Hospitalieres Industrie
Orthopedic · 38d
Cleared Oct 07, 2004
SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS
K042356 · HWC
Synthes (Usa)
Orthopedic · 37d
Cleared Oct 07, 2004
LOCON VLS DISTAL RADIUS PLATE SYSTEM
K042358 · KTT
Wrightmedicaltechnologyinc
Orthopedic · 37d
Cleared Oct 07, 2004
SYNTHES LOW PROFILE RECONSTRUCTION PLATES
K042377 · HRS
Synthes (Usa)
Orthopedic · 36d
Cleared Oct 07, 2004
IIIZAROV PULLEY SYSTEM
K042436 · KTT
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Oct 07, 2004
ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM
K042440 · HSB
Alphatec/Nexmed
Orthopedic · 28d
Cleared Oct 07, 2004
MODIFICATION TO EQUATION FIXATION SYSTEM
K042453 · MNI
Medtronic Sofamor Danek, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM
K042458 · LXT
A.M. Surgical, Inc.
Orthopedic · 27d
Cleared Oct 07, 2004
VERTEX RECONSTRUCTION SYSTEM
K042498 · KWP
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · KWQ
Medtronic Sofamor Danek
Orthopedic · 23d
Cleared Oct 07, 2004
SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM
K042508 · KWP
Depuy Spine, Inc.
Orthopedic · 22d
Cleared Oct 07, 2004
MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM
K042514 · MNI
Blackstone Medical, Inc.
Orthopedic · 21d
Cleared Oct 05, 2004
AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR
K041698 · MAI
Axya Medical, Inc.
Orthopedic · 105d
Cleared Oct 05, 2004
ACUMED ANATOMIC RADIAL HEAD SYSTEM
K041858 · KWI
Acumed, LLC
Orthopedic · 88d
Cleared Oct 04, 2004
EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS
K040601 · KWZ
Exactech, Inc.
Orthopedic · 210d
Cleared Oct 01, 2004
EXACTECH OPTETRAK UNICONDYLAR KNEE
K040889 · HRY
Exactech, Inc.
Orthopedic · 179d
Cleared Oct 01, 2004
SYNTHES CONTOURED SYNMESH SPACER
K041389 · MQP
Synthes Spine
Orthopedic · 129d
Cleared Oct 01, 2004
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
K041808 · KWP
Endius, Inc.
Orthopedic · 87d
Cleared Oct 01, 2004
M2A MAGNUM SYSTEM
K042037 · KWA
Biomet, Inc.
Orthopedic · 64d
Cleared Oct 01, 2004
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K042402 · KWP
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Sep 30, 2004
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
K040630 · JWH
Implex Corp.
Orthopedic · 204d