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
16441–16464 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 19, 1989
BIOLOX CERAMIC BALL
K892644 · LZO
Allo Pro Corp.
Orthopedic · 190d
Cleared Oct 19, 1989
DELTA-TECH(TM) CAST REMOVAL SYSTEM
K895861 · LGH
Johnson & Johnson Professionals, Inc.
Orthopedic · 16d
Cleared Oct 17, 1989
WHITESIDE ORTHOLOC M.A. TIBIAL BASE
K894504 · JWH
Dow Corning Wright
Orthopedic · 90d
Cleared Oct 16, 1989
SMALL JOINT HAND INSTRUMENTS
K895685 · HRX
Leonard Medical, Inc.
Orthopedic · 24d
Cleared Oct 13, 1989
FREEMAN TOTAL HIP SYSTEM RIDGED STEM
K890331 · LWJ
Orthopedic Systems, Inc.
Orthopedic · 263d
Cleared Oct 13, 1989
FREEMAN MODULAR HIP STEM RIDGED VERSION
K890498 · JDI
Orthopedic Systems, Inc.
Orthopedic · 254d
Cleared Oct 12, 1989
OMNIFIT CERAMIC MORSE TAPER HEAD
K894694 · LZO
Osteonics Corp.
Orthopedic · 80d
Cleared Oct 11, 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640 · JDL
Arrow Intl., Inc.
Orthopedic · 182d
Cleared Oct 11, 1989
STUART CD UNIVERSAL ROD CONNECTOR CLAMPS
K894702 · KWP
Bio-Medical Prosthetics
Orthopedic · 76d
Cleared Oct 10, 1989
CROSS ROUND & SQUARE SPINAL RODS & DIST. SPINAL
K894472 · KWP
Buckman Co., Inc.
Orthopedic · 84d
Cleared Oct 10, 1989
PT DISTAL TIP CEMENT SPACER
K894708 · JDK
Osteonics Corp.
Orthopedic · 78d
Cleared Oct 06, 1989
INTERMEDICS HIGH TIBIAL OSTEOTOMY SYSTEM
K892228 · HRS
Intermedics Orthopedics
Orthopedic · 184d
Cleared Oct 06, 1989
MITEK ANCHOR DRILL
K892903 · HTW
Mitek Surgical Products, Inc.
Orthopedic · 169d
Cleared Oct 06, 1989
SECOND GENERATION KNEE SYSTEM
K894334 · JWH
Orthomet, Inc.
Orthopedic · 84d
Cleared Sep 29, 1989
MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS
K885229 · HSZ
Romano Surgical Instrumentation, Inc.
Orthopedic · 294d
Cleared Sep 28, 1989
ACL DRILL GUIDE SYSTEM
K892655 · LXI
Baxter Healthcare Corp
Orthopedic · 168d
Cleared Sep 28, 1989
MITEK DRILL GUIDE
K892904 · HXY
Mitek Surgical Products, Inc.
Orthopedic · 161d
Cleared Sep 27, 1989
MODIFIED GEMINI ACETABULAR CUP
K894298 · JDI
Depuy, Inc.
Orthopedic · 97d
Cleared Sep 26, 1989
CERAMIC FEMORAL HEAD
K893685 · LZO
Dow Corning Wright
Orthopedic · 133d
Cleared Sep 19, 1989
MITEK ANCHOR
K892126 · JDR
Mitek Surgical Products, Inc.
Orthopedic · 173d
Cleared Sep 15, 1989
PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT
K893762 · JWH
Orthomet, Inc.
Orthopedic · 119d
Cleared Sep 15, 1989
HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM
K895198 · HWE
Zimmer, Inc.
Orthopedic · 35d
Cleared Sep 14, 1989
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K894149 · JDI
Howmedica Corp.
Orthopedic · 92d
Cleared Sep 13, 1989
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · HTY
Buckman Co., Inc.
Orthopedic · 30d