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
15961–15984 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Nov 22, 1991
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K913812 · JDI
Osteonics Corp.
Orthopedic · 88d
Cleared Nov 21, 1991
ACE OPEN-BACK HALO RING
K914858 · JEC
Ace Medical Co.
Orthopedic · 23d
Cleared Nov 18, 1991
SONGER(TM) CABLE SYSTEM
K913735 · JDQ
Danek Medical, Inc.
Orthopedic · 90d
Cleared Nov 15, 1991
SURETAC POLYGLYCONATE ABSORBABLE FIXATION DEVICE
K911837 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 204d
Cleared Nov 13, 1991
JOHNSON AND JOHNSON POWER SYSTEM
K913629 · HSZ
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 90d
Cleared Nov 13, 1991
BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM
K913632 · KWY
Kirschner Medical Corp.
Orthopedic · 90d
Cleared Nov 13, 1991
MODULAR CALCAR REPLACEMENT
K913649 · JDI
Zimmer, Inc.
Orthopedic · 89d
Cleared Nov 07, 1991
OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR
K913559 · HSZ
Osteo AG
Orthopedic · 90d
Cleared Nov 07, 1991
LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
K913616 · JDI
Implant Technology, Inc.
Orthopedic · 86d
Cleared Nov 07, 1991
SPIKED WASHER
K914472 · HTN
Synthes (Usa)
Orthopedic · 31d
Cleared Nov 05, 1991
PGK STEREOTACTIC DEVICE
K911974 · HRX
Northern Virginia Radiology and...
Orthopedic · 186d
Cleared Oct 29, 1991
AESCULAP TITANIUM BONE SCREWS
K913415 · HWC
Aesculap, Inc.
Orthopedic · 90d
Cleared Oct 25, 1991
RAY SACRAL FIXATION SYSTEM
K904520 · KWP
Danek Medical, Inc.
Orthopedic · 387d
Cleared Oct 25, 1991
FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT
K911972 · JWH
Intermedics Orthopedics
Orthopedic · 175d
Cleared Oct 24, 1991
CROSSLINK PLATE
K911307 · KWP
Danek Medical, Inc.
Orthopedic · 213d
Cleared Oct 23, 1991
P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL
K914439 · HSX
Johnson & Johnson Orthopaedics, Inc.
Orthopedic · 19d
Cleared Oct 21, 1991
LIMA RPS SHOULDER
K913282 · HSD
Turnkey Intergration USA, Inc.
Orthopedic · 89d
Cleared Oct 18, 1991
AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
K912894 · JWH
Orthomet, Inc.
Orthopedic · 109d
Cleared Oct 18, 1991
HYBRID FIT TOTAL HIP SYSTEM
K913246 · JDI
Kirschner Medical Corp.
Orthopedic · 88d
Cleared Oct 17, 1991
OSTEO BONE PLATED
K913271 · HRS
Fred C. Bryson
Orthopedic · 86d
Cleared Oct 15, 1991
TRUE/FLEX TIBIAL RODS WITH CAP
K912710 · HSB
Applied Osteo Systems, Inc.
Orthopedic · 118d
Cleared Oct 15, 1991
FASTLOK (STAPLE & BUCKLE) FIXATION SYSTEM
K913461 · JDR
Neoligaments, Ltd.
Orthopedic · 71d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT)
K912369 · MEH
Biomet, Inc.
Orthopedic · 135d
Cleared Oct 11, 1991
HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES)
K912370 · MEH
Biomet, Inc.
Orthopedic · 135d