510k
Database
Specialties
Anesthesiology
330
Cardiovascular
1055
Chemistry
268
Dental
793
Ear, Nose, Throat
148
Gastroenterology & Urology
619
General & Plastic Surgery
1307
General Hospital
746
Hematology
97
Immunology
72
Medical Genetics
1
Microbiology
364
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566
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240
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154
Orthopedic
2032
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38
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309
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1570
Toxicology
130
Categories
GEX
Powered Laser Surgical Instrument
227
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Plate, Fixation, Bone
208
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System, Imaging, Pulsed Doppler,...
207
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Automated Radiological Image...
204
LLZ
System, Image Processing,...
197
GEI
Electrosurgical, Cutting &...
185
OLO
Orthopedic Stereotaxic Instrument
168
NHA
Abutment, Implant, Dental,...
153
MAX
Intervertebral Fusion Device...
137
NKB
Thoracolumbosacral Pedicle Screw...
133
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Osteotech, Inc.
Medical Device Manufacturer
·
US , San Mateo , CA
Osteotech, Inc. - FDA 510(k) Cleared Devices
24 submissions
·
21 cleared
·
Since 1985
24
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Osteotech, Inc.
Dental
✕
3
devices
1-3 of 3
Filters
Cleared
Jan 03, 2006
GRAFTON DBM
K051188
·
NUN
Dental
·
238d
Cleared
Nov 30, 2005
GRAFTON PLUS DBM PASTE
K042707
·
NUN
Dental
·
426d
Cleared
Oct 07, 1985
OSTEOGRAF 2040 OSTEOGRAF 4060
K852199
·
LYC
Dental
·
140d
Filters
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24
Orthopedic
19
Dental
3
Pathology
1
General & Plastic Surgery
1