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
15865–15888 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Apr 20, 1992
OSTEONICS MICROSURFACED CDH HIP STEM
K920250 · JDI
Stryker Corp.
Orthopedic · 90d
Cleared Apr 13, 1992
BIOMET NTS FEMORAL COMPONENTS
K920161 · JDI
Biomet, Inc.
Orthopedic · 90d
Cleared Apr 10, 1992
PWB LUMBOSACRAL SPINE SYSTEM
K920116 · KWP
Cross Medical Products, Inc.
Orthopedic · 88d
Cleared Apr 09, 1992
OSTEO EX-FI-RE
K920149 · JEC
Osteo AG
Orthopedic · 90d
Cleared Apr 08, 1992
TITANIUM ALLOY SONGER CABLE SYSTEM
K920201 · JDQ
Sofamor Danek Mfg., Inc.
Orthopedic · 84d
Cleared Apr 01, 1992
MOD. TROCHANTER SCREW & WASHER W/ ANODIZED TITAN.
K910664 · LWJ
Medimix Products, Inc.
Orthopedic · 412d
Cleared Mar 25, 1992
LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
K920021 · JDI
Implant Technology, Inc.
Orthopedic · 83d
Cleared Mar 23, 1992
CROSSLINK SYSTEM
K911663 · KWP
Synthes (Usa)
Orthopedic · 346d
Cleared Mar 23, 1992
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K915868 · KWL
Orthomet, Inc.
Orthopedic · 84d
Cleared Mar 19, 1992
MODEL AR-6300 INFUSION PUMP
K915721 · HRX
Arthrex, Inc.
Orthopedic · 90d
Cleared Mar 19, 1992
S-ROM LF FEMORAL HEAD
K920317 · JDI
Joint Medical Products Corp.
Orthopedic · 55d
Cleared Mar 18, 1992
DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
K920034 · JWH
Pfizer Hospital Products Group, Inc.
Orthopedic · 72d
Cleared Mar 16, 1992
BREMER HALO SYSTEM CERVICAL TRACTION SKULL PIN
K915800 · JEC
Bremer Medical, Inc.
Orthopedic · 83d
Cleared Mar 13, 1992
DRG CEMETED STEM
K920003 · JDI
Intermedics Orthopedics
Orthopedic · 71d
Cleared Mar 12, 1992
AESCULAP TITANIUM BONE PLATES
K913730 · KWQ
Aesculap, Inc.
Orthopedic · 205d
Cleared Mar 11, 1992
BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD
K915596 · KWT
Biomet, Inc.
Orthopedic · 89d
Cleared Mar 10, 1992
IONGUARD TITANIUM MODULAR HEADS
K915548 · LZY
Biomet, Inc.
Orthopedic · 90d
Cleared Mar 06, 1992
SUCTION CONTROL FOOTSWITCH WITH SPEED CONTROL
K913401 · HRX
Smith & Nephew Dyonics, Inc.
Orthopedic · 220d
Cleared Mar 04, 1992
PERFECTA PDA TOTAL HIP SYSTEM
K915795 · JDI
Orthomet, Inc.
Orthopedic · 65d
Cleared Mar 02, 1992
INTERLOCKING TIBIAL NAILING SYSTEM
K915435 · HSB
Stryker Corp.
Orthopedic · 90d
Cleared Feb 28, 1992
CORTICAL BONE SCREW
K915448 · HWC
Dow Corning Wright
Orthopedic · 81d
Cleared Feb 20, 1992
AAP BONE PLATE
K915315 · HRS
Aap International, Ltd.
Orthopedic · 90d
Cleared Feb 19, 1992
KINAMED 22MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915309 · LZO
Kinamed, Inc.
Orthopedic · 89d
Cleared Feb 19, 1992
KINAMED 28MM BIOCERAM-Z TOTAL HIP FEMORAL BALL
K915310 · LZO
Kinamed, Inc.
Orthopedic · 89d