510k
Database
Specialties
Anesthesiology
464
Cardiovascular
1399
Chemistry
334
Dental
1094
Ear, Nose, Throat
201
Gastroenterology & Urology
827
General & Plastic Surgery
1838
General Hospital
1311
Hematology
124
Immunology
86
Medical Genetics
7
Microbiology
420
Neurology
786
Obstetrics & Gynecology
351
Ophthalmic
222
Orthopedic
2447
Pathology
47
Physical Medicine
418
Radiology
2023
Toxicology
144
Categories
GEX
Powered Laser Surgical Instrument
300
LLZ
System, Image Processing,...
296
GEI
Electrosurgical, Cutting &...
256
QIH
Automated Radiological Image...
254
IYN
System, Imaging, Pulsed Doppler,...
244
HRS
Plate, Fixation, Bone
241
LZA
Polymer Patient Examination Glove
228
OLO
Orthopedic Stereotaxic Instrument
200
NHA
Abutment, Implant, Dental,...
190
MAX
Intervertebral Fusion Device...
169
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Orthopedic Designs, Inc.
Medical Device Manufacturer
·
US , St. Petersburg , FL
Orthopedic Designs, Inc. - FDA 510(k) Cleared Devices
4 submissions
·
3 cleared
·
Since 1998
4
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Orthopedic Designs, Inc.
Orthopedic
✕
4
devices
1-4 of 4
Filters
Cleared
Apr 01, 2003
ODI 7.0MM CANNULATED SCREW SYSTEM
K030619
·
HTN
Orthopedic
·
33d
Cleared
Mar 21, 2002
ODI TALON INTRAMEDULLARY HIP NAIL
K014189
·
JDS
Orthopedic
·
90d
Cleared
Jan 20, 1999
ODI ULTIMATE COMPRESSION HIP SCREW
K984331
·
HWC
Orthopedic
·
48d
Cleared
Jan 23, 1998
ULTIMATE COMPRESSION SCREW SYSTEM
K972722
·
HWC
Orthopedic
·
186d
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Orthopedic
4