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
13441–13464 of 17,985
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 02, 1999
TALON ANCHOR SNAP-PAK
K993261 · MBI
Mitek Products
Orthopedic · 64d
Cleared Dec 02, 1999
DURACON INSET PATELLA, 25MM
K993692 · JWH
Howmedica Osteonics Corp.
Orthopedic · 30d
Cleared Dec 01, 1999
APR METASUL ACETABULAR INSERT
K993569 · KWA
Sulzermedica
Orthopedic · 41d
Cleared Nov 23, 1999
ZYRANOX ZIRCONIA CERAMIC FEMORAL HEADS
K992235 · LZO
Corin USA
Orthopedic · 144d
Cleared Nov 23, 1999
EBI SPINELINK SYSTEM
K992920 · MNI
Ebi, L.P.
Orthopedic · 85d
Cleared Nov 23, 1999
PIONEER SILICOAT STERNAL CABLE
K993286 · JDQ
Pioneer Surgical Technology
Orthopedic · 53d
Cleared Nov 22, 1999
ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE
K993540 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 34d
Cleared Nov 19, 1999
VERSALOK LOW BACK FIXATION SYSTEM
K992885 · KWP
Osteotech, Inc.
Orthopedic · 84d
Cleared Nov 19, 1999
STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM
K993061 · MAI
Stryker Instruments
Orthopedic · 67d
Cleared Nov 19, 1999
EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR...
K993082 · LPH
Exactech, Inc.
Orthopedic · 65d
Cleared Nov 19, 1999
CROSSFIRE SYSTEM 12 ACETABULAR INSERTS
K993352 · LPH
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Nov 19, 1999
WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW
K993603 · HSB
Howmedica Osteonics Corp.
Orthopedic · 25d
Cleared Nov 19, 1999
EBI XFIX DFS WRISTFIX SYSTEM
K993649 · KTT
Ebi, L.P.
Orthopedic · 21d
Cleared Nov 18, 1999
RCI FIXATION SCREWS (WITH ASSORTED SIZES)
K992945 · HWC
Smith & Nephew, Inc.
Orthopedic · 78d
Cleared Nov 16, 1999
BONE BULLET SUTURE ANCHOR
K991024 · HWC
Linvatec Corp.
Orthopedic · 232d
Cleared Nov 16, 1999
FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM
K992287 · HSX
Howmedica Osteonics Corp.
Orthopedic · 132d
Cleared Nov 16, 1999
XIA SPINAL SYSTEM C-C ADAPTOR
K992792 · KWQ
Howmedica Osteonics Corp.
Orthopedic · 89d
Cleared Nov 16, 1999
SILHOUETTE SPINAL FIXATION SYSTEM
K993067 · KWP
Sulzer Spine-Tech
Orthopedic · 64d
Cleared Nov 16, 1999
MODIFIED BMP TROCHANTERIC PLATES
K993510 · HRS
Biomet, Inc.
Orthopedic · 29d
Cleared Nov 16, 1999
HOWMEDICA OSTEONICS FEMORAL HEADS
K993601 · LWJ
Howmedica Osteonics Corp.
Orthopedic · 22d
Cleared Nov 16, 1999
MODIFIED LONG LENGTH GAMMA NAIL
K993670 · HSB
Howmedica Osteonics Corp.
Orthopedic · 15d
Cleared Nov 10, 1999
FS 1000 KNEE SYSTEM
K991052 · JWH
Renaissance Instruments, LLC
Orthopedic · 225d
Cleared Nov 10, 1999
THE TAPER-FIT TOTAL HIP SYSTEM
K992234 · JDG
Corin USA
Orthopedic · 131d
Cleared Nov 10, 1999
METRX SYSTEM
K993021 · HRX
Surgical Navigation Technologies, Inc.
Orthopedic · 63d