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
11545–11568 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Sep 08, 2004
SYNTHES (USA) LCP CURVED PLATES
K041911 · KTT
Synthes (Usa)
Orthopedic · 55d
Cleared Sep 08, 2004
BIOPRO SUBTALAR IMPLANT
K041936 · HWC
Biopro, Inc.
Orthopedic · 51d
Cleared Sep 08, 2004
ARTHREX HUMERAL FRACTURE PLATES AND SCREWS
K041965 · HRS
Arthrex, Inc.
Orthopedic · 49d
Cleared Sep 08, 2004
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K042167 · NKB
Medtronic Sofamor Danek
Orthopedic · 28d
Cleared Sep 08, 2004
TROCHANTERIC NAIL SYSTEM
K042325 · HSB
DePuy Orthopaedics, Inc.
Orthopedic · 12d
Cleared Sep 03, 2004
OUTOLOGOUS SPINAL FIXATION SYSTEM
K040493 · MNI
Orthopedic Sciences, Inc.
Orthopedic · 190d
Cleared Sep 03, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K041777 · MNI
Medtronic Sofamor Danek
Orthopedic · 64d
Cleared Sep 01, 2004
SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS
K041533 · HWC
Synthes (Usa)
Orthopedic · 85d
Cleared Sep 01, 2004
ZIMMER TRABECULAR METAL HUMERAL STEM
K041549 · KWT
Zimmer, Inc.
Orthopedic · 84d
Cleared Aug 31, 2004
OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM
K041089 · MQV
Biomet Manufacturing, Inc.
Orthopedic · 127d
Cleared Aug 27, 2004
EXPANDABLE PEEK VBR IMPLANT
K040928 · MQP
Interpore Cross Intl.
Orthopedic · 140d
Cleared Aug 27, 2004
DURASUL BIPOLAR
K040947 · KWY
Centerpulse Orthopedics, Inc.
Orthopedic · 137d
Cleared Aug 27, 2004
SURFIX KNEE OSTEOTOMY SYSTEM
K041601 · HRS
Surfix Technologies
Orthopedic · 74d
Cleared Aug 27, 2004
ENDOTINE FOREHEAD TRIPLE DEVICE
K042078 · HWC
Coapt Systems, Inc.
Orthopedic · 25d
Cleared Aug 26, 2004
NAME BONE VOID FILLER
K041421 · MQV
Stryker Biotech
Orthopedic · 90d
Cleared Aug 25, 2004
BICONTACT HIP STEM AND FEMORAL HEAD
K040191 · LPH
Aesculap
Orthopedic · 210d
Cleared Aug 25, 2004
MODIFICATION TO RESTORATION MODULAR SYSTEM
K040734 · LZO
Howmedica Osteonics Corp.
Orthopedic · 156d
Cleared Aug 25, 2004
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30,...
K041451 · KYI
Ascension Orthopedics, Inc.
Orthopedic · 85d
Cleared Aug 25, 2004
SNAP-OFF SCREWS
K041456 · HWC
Fournitures Hospitalieres Industrie
Orthopedic · 85d
Cleared Aug 25, 2004
NOVABONE - AR - RESORBABLE BONE GRAFT SUBSTITUTE
K041613 · MQV
Novabone Products, LLC
Orthopedic · 71d
Cleared Aug 25, 2004
BGRAN SYNTHETIC OSTEOCONDUCTIVE SCAFFOID
K041616 · MQV
Orthos (Uk) Limited
Orthopedic · 71d
Cleared Aug 25, 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
K041873 · PHX
Tornier
Orthopedic · 44d
Cleared Aug 25, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · KWQ
Medtronic Sofamor Danek, Inc.
Orthopedic · 28d
Cleared Aug 25, 2004
KLSA MARTIN HAND DISTRACTOR
K042066 · JEC
KLS-Martin L.P.
Orthopedic · 23d