510k
Database
Specialties
Anesthesiology
542
Cardiovascular
1680
Chemistry
365
Dental
1337
Ear, Nose, Throat
248
Gastroenterology & Urology
972
General & Plastic Surgery
2194
General Hospital
2047
Hematology
126
Immunology
99
Medical Genetics
8
Microbiology
469
Neurology
965
Obstetrics & Gynecology
433
Ophthalmic
275
Orthopedic
2923
Pathology
52
Physical Medicine
515
Radiology
2442
Toxicology
155
Categories
LZA
Polymer Patient Examination Glove
409
LLZ
System, Image Processing,...
388
FXX
Mask, Surgical
358
GEX
Powered Laser Surgical Instrument
356
GEI
Electrosurgical, Cutting &...
305
IYN
System, Imaging, Pulsed Doppler,...
299
QIH
Automated Radiological Image...
276
HRS
Plate, Fixation, Bone
275
OLO
Orthopedic Stereotaxic Instrument
227
MAX
Intervertebral Fusion Device...
220
Browse all 339 categories →
Search
Reports
Glossary
About
Home
Promethean Restorative, LLC
Medical Device Manufacturer
·
US , Castle Rock , CO
Promethean Restorative, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2025
Official Website
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Promethean Restorative, LLC
Orthopedic
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 12, 2026
DYNAMIS™ Navigation System
K252962
·
OLO
Orthopedic
·
118d
Cleared
Apr 25, 2025
DYNAMIS™ Implant System
K251075
·
OUR
Orthopedic
·
17d
Cleared
Feb 28, 2025
DYNAMIS™ SI Screw System
K243565
·
OUR
Orthopedic
·
102d
Filters
Filter by Specialty
All
3
Orthopedic
3