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
13585–13608 of 17,850
Search insights Median review: 89d Cleared: 100% Top manufacturer: Biomet, Inc. Lead specialty: Orthopedic
Cleared Jan 21, 1999
SYNTHES SPINE CERVIFIX SYSTEM
K984377 · KWP
Synthes (Usa)
Orthopedic · 49d
Cleared Jan 20, 1999
MICOMED - HALM ZIELKE INSTRUMENTATION
K982006 · KWQ
Micomed GmbH
Orthopedic · 226d
Cleared Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331 · HWC
Orthopedic Designs, Inc.
Orthopedic · 48d
Cleared Jan 20, 1999
TIMX LOW BACK SYSTEM
K984348 · MNI
Depuy Motech Acromed
Orthopedic · 47d
Cleared Jan 20, 1999
VSP SYSTEM
K984350 · MNI
Depuy Motech Acromed
Orthopedic · 47d
Cleared Jan 19, 1999
MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM
K982875 · KWQ
Danek Medical, Inc.
Orthopedic · 158d
Cleared Jan 19, 1999
EBI SPINELINK SYSTEM
K984027 · MNI
Electro-Biology, Inc.
Orthopedic · 68d
Cleared Jan 19, 1999
THE NEW BIO-MOORE ENDO HEADS
K984028 · KWL
Biomet, Inc.
Orthopedic · 68d
Cleared Jan 19, 1999
SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM
K984612 · MNI
Synthes Spine
Orthopedic · 26d
Cleared Jan 14, 1999
GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM
K983814 · JDO
Efratgo, Ltd. HI Tech Bio-Surgical
Orthopedic · 78d
Cleared Jan 14, 1999
GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD
K984541 · KWT
DePuy Orthopaedics, Inc.
Orthopedic · 24d
Cleared Jan 06, 1999
MODIFICATION OF TSRH SPINAL SYSTEM
K984522 · MNI
Danek Medical, Inc.
Orthopedic · 16d
Cleared Dec 31, 1998
DEPUY ACE SPIDER PLATE
K984458 · HRS
Depuy Ace Medical Co.
Orthopedic · 16d
Cleared Dec 30, 1998
BODYFORM THORACO-LUMBAR FIXATION SYSTEM
K983622 · KWQ
Theken Surgical,Llc
Orthopedic · 76d
Cleared Dec 30, 1998
SYNTEC-TAICHUNG NON-STERILE DHS/DCS PLATE SYSTEM
K983873 · KTT
Syntec Scientific Corp.
Orthopedic · 58d
Cleared Dec 30, 1998
METAGEN ACTIVELOCK WIRE CERCLAGE SYSTEM
K983976 · JDQ
Metagen, LLC
Orthopedic · 51d
Cleared Dec 30, 1998
ANTERIOR CERVICAL PLATING SYSTEM
K984342 · KWQ
United States Surgical, A Division of...
Orthopedic · 26d
Cleared Dec 30, 1998
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378 · MNI
Depuy, Inc.
Orthopedic · 23d
Cleared Dec 22, 1998
PHUSIS ABSORBABLE INTERFERENCE SCREW
K970829 · HWC
Tornier
Orthopedic · 656d
Cleared Dec 22, 1998
TYPE 3 FEMORAL COMPONENTS
K983404 · LZO
Howmedica Corp.
Orthopedic · 85d
Cleared Dec 22, 1998
DEPUY ACE TIMAX META PLATE
K983853 · HRS
Depuy Ace Medical Co.
Orthopedic · 53d
Cleared Dec 22, 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · KWQ
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 22, 1998
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · KWP
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 18, 1998
CD SPINAL SYSTEM
K980184 · MNI
Sofamor Danek USA,Inc.
Orthopedic · 332d