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
16177–16200 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Dec 11, 1990
BLADE PLATE
K905352 · KTT
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
BARBED SQUARE STAPLE
K905362 · JDR
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
FIXATION STAPLE
K905363 · JDR
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 11, 1990
ROUND STAPLE
K905364 · JDR
O'Tec Corp.
Orthopedic · 13d
Cleared Dec 10, 1990
TSRH SPINAL SYSTEM (ADD'L SIZES OF HOOKS)
K901005 · KWP
Danek Medical, Inc.
Orthopedic · 283d
Cleared Dec 10, 1990
KNIGHT SACRAL SCREW
K902775 · KWP
Danek Medical, Inc.
Orthopedic · 168d
Cleared Dec 05, 1990
TSRH OFFSET AND SIDE-LOADING HOOKS
K903461 · KWP
Danek Medical, Inc.
Orthopedic · 126d
Cleared Dec 05, 1990
ARTHROSCOPIC SURGICAL BLADE
K904284 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 79d
Cleared Dec 05, 1990
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · JDI
Howmedica Corp.
Orthopedic · 41d
Cleared Dec 05, 1990
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · JDI
Depuy, Inc.
Orthopedic · 35d
Cleared Nov 27, 1990
ORIGIN(TM) CEMENT EXTRACT SYST STD-PR/SPL-PR KITS
K904156 · LZV
Origin Medsystems, Inc.
Orthopedic · 81d
Cleared Nov 26, 1990
ACE/WILLIAMS MICROSURGERY SAW SYSTEM
K902525 · HWE
Buckman Co., Inc.
Orthopedic · 174d
Cleared Nov 26, 1990
VSP HIP STEM
K903957 · JDI
Turnkey Intergration USA, Inc.
Orthopedic · 90d
Cleared Nov 26, 1990
A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERS
K904949 · HSZ
Micro-Aire Surgical Instruments, Inc.
Orthopedic · 24d
Cleared Nov 20, 1990
OSTEONICS SR GLENOID COMPONENTS
K903886 · KWS
Osteonics Reconstructive Products Div.
Orthopedic · 90d
Cleared Nov 20, 1990
PROSTHETIC CEMENT REMOVER
K904180 · LZV
Origin Medsystems, Inc.
Orthopedic · 70d
Cleared Nov 20, 1990
S-ROM(TM) FEMORAL STEM CENTRALIZER/CEMENT SPACER
K904746 · JDK
Joint Medical Products Corp.
Orthopedic · 33d
Cleared Nov 09, 1990
PERFECTA TOTAL HIP SYSTEM
K903635 · JDI
Orthomet, Inc.
Orthopedic · 88d
Cleared Nov 05, 1990
TSRH SACRAL L-CONNECTOR
K901587 · KWP
Danek Medical, Inc.
Orthopedic · 215d
Cleared Nov 05, 1990
MODULOCK POSTERIOR SPINAL FIXATION
K902397 · KWP
Zimmer, Inc.
Orthopedic · 159d
Cleared Nov 02, 1990
SURGICAL INST.:1030,1010,1011,1012,1013,1014,1015
K904479 · HRX
Percutaneous Technologies
Orthopedic · 31d
Cleared Oct 30, 1990
LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
K902056 · JDY
Hollister, Inc.
Orthopedic · 176d
Cleared Oct 30, 1990
SURGICAL DYNAMICS NUCLEOTOME II TISSUE ASPIR/CUTER
K902778 · HRX
Surgical Dynamics, Inc.
Orthopedic · 127d
Cleared Oct 30, 1990
OSTEONICS DRM ACETABULAR COMPONENT
K903636 · JDI
Osteonics Corp.
Orthopedic · 78d