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
15169–15192 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Oct 11, 1994
ENDOSCOPIC PLANTAR FASCIA KIT
K940847 · HRX
Citation Medical Corp.
Orthopedic · 230d
Cleared Oct 11, 1994
COHORT BONE BRUSH
K942108 · HWE
Advanced Med/Surg, Inc.
Orthopedic · 162d
Cleared Oct 07, 1994
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
K931752 · KWL
Corin Orthopedic Products
Orthopedic · 547d
Cleared Oct 07, 1994
CORIN THOMPSON PROSTHESIS, MODIFICATION
K931753 · KWL
Corin Orthopedic Products
Orthopedic · 547d
Cleared Oct 07, 1994
NUFFIELD TOTAL KNEE
K931960 · JWH
Turnkey Intergration USA, Inc.
Orthopedic · 534d
Cleared Oct 07, 1994
MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
K934366 · HWC
Mitek Surgical Products, Inc.
Orthopedic · 395d
Cleared Oct 07, 1994
GALILEO ARTHROSCOPES
K934707 · HRX
Galileo Electro-Optics Corp.
Orthopedic · 372d
Cleared Oct 07, 1994
3M FLUID IRRIGATION SYSTEM
K941388 · HRX
3M Healthcare
Orthopedic · 199d
Cleared Oct 07, 1994
3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD
K941718 · HRX
3M Medical Products Group
Orthopedic · 183d
Cleared Oct 06, 1994
P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT
K935452 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 328d
Cleared Oct 06, 1994
APR ACETABULAR INSERT
K941617 · JDI
Intermedics Orthopedics
Orthopedic · 185d
Cleared Oct 05, 1994
ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT
K940235 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 260d
Cleared Oct 05, 1994
OPTION SHELL
K942406 · JDI
Intermedics Orthopedics
Orthopedic · 138d
Cleared Oct 04, 1994
SPINE-TECH LAPAROSCOPIC INSTRUMENTATION SYSTEM
K940913 · HRX
Spine-Tech, Inc.
Orthopedic · 221d
Cleared Oct 04, 1994
APR II FEMORAL COMPONENT (VARIOUS)
K942330 · LZO
Intermedics Orthopedics
Orthopedic · 141d
Cleared Oct 04, 1994
OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM
K943054 · LPH
Osteonics Corp.
Orthopedic · 99d
Cleared Oct 03, 1994
S-ROM NOILES CRUCIATE RETAINING KNEE
K936037 · JWH
Joint Medical Products Corp.
Orthopedic · 287d
Cleared Oct 03, 1994
TRUE/LOK MONOLATERAL/BILATERAL FIXATOR
K941048 · LXT
Applied Osteo Systems, Inc.
Orthopedic · 210d
Cleared Oct 03, 1994
K-WIRES AND STEINMANN PINS
K941434 · HTY
Omega Surgical Instruments, Inc.
Orthopedic · 193d
Cleared Sep 30, 1994
4-LEAD IRRIGATION SET
K942101 · HRX
Douglas Medical Products Corp.
Orthopedic · 151d
Cleared Sep 30, 1994
INTERFERENCE SCREW
K943160 · HWC
Applied Osteo Systems, Inc.
Orthopedic · 91d
Cleared Sep 29, 1994
ULTIMA UNIPOLAR MODULAR HEAD
K940190 · KWL
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 259d
Cleared Sep 28, 1994
ALPHATEC 130-150 SLOTTED COMPRESSION HIP SCREW
K926417 · KTT
Alphatec Mfg., Inc.
Orthopedic · 644d
Cleared Sep 28, 1994
P.F.C. CERAMIC HIP HEAD
K933275 · LZO
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 449d