FDA Registration Active 🇺🇸 United States

CENTERED ALTO NYTEBYTE PARTIAL

Reg #: 1057421 · FEI: 1000022662 · Expires 2025
Products
2
Proprietary Names
96
Establishment Types
1
Classifications
2

Registration Details

Registration Name
GRACE MEDICAL, INC.
Registration Number
1057421
FEI Number
1000022662
Status
Active
Expiry Year
2025
Initial Importer
No
Address
8500 WOLF LAKE DR. SUITE 110
City
Memphis
State
TN
ZIP
38133
Country
US

Regulatory Submissions

510(k) Number
K061853

Owner / Operator

Firm Name
GRACE MEDICAL GROUP, INC.
Operator Number
9067138
Address
8500 WOLF LAKE DR., SUITE 110
City
Memphis
State
TN
Postal Code
38133
Country
US

Products

Device Name Product Code
Replacement, Ossicular Prosthesis, Total ETA
Prosthesis, Partial Ossicular Replacement ETB

Proprietary Names

CENTERED ALTO NYTEBYTE PARTIAL BOJRAB ALTO TOTAL CENTERED DUO ALTO TOTAL W/STAPES ADAPTER HA LITE ALTO PARTIAL CENTERED ALTO BYTE PARTIAL MIAMI IS COUPLER PARTIAL – SHORT SILVERSTEIN ALTO TOTAL W/TACK PRECISE TOTAL DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS DORNHOFFER ALTO TOTAL PRECISE CENTERED TOTAL 20MM L SATALOFF ALTO PARTIAL OWENS ASSURE ALTO TOTAL HA ALTO PARTIAL WILDCAT PRO, 5.50MM L CENTERED ALTO PARTIAL DORNHOFFER ALTO PARTIAL W/WINDOWS PRECISE OFFSET TOTAL CENTERED ALTO PARTIAL 10MM L HA LITE ALTO TOTAL W/INTEGRATED SHOE WILDCAT PRO, 3.50MM L PRECISE OWENS ASSURE PARTIAL OWENS ASSURE ALTO TOTAL W/INTEGRATED SHOE WILDCAT FIXED LENGTH TOTAL MIAMI IS COUPLER PARTIAL – LONG OFFSET NANO ALTO TOTAL DORNHOFFER ALTO PARTIAL BOJRAB ALTO PRECUT WILDCAT PRO, 50MM L BOJRAB DUO ALTO TOTAL OFFSET NANO ALTO PARTIAL PRECISE CENTERED NYTEBYTE PARTIAL OWENS ASSURE ALTO PARTIAL HA WILDCAT FIXED LENGTH TOTAL CENTERED ALTO CONCISE PARTIAL PRECISE CENTERED PARTIAL PRECISE OFFSET PARTIAL HA LITE ALTO BOJRAB FOOTPLATE SHOE CENTERED ALTO TOTAL CENTERED NANO ALTO PARTIAL GANTZ ALTO TOTAL VINCENT TOTAL Grace Medical DORNHOFFER ALTO NYTEBYTE PARTIAL HABERMAN ALTO PARTIAL ROUND HEAD HABERMAN ALTO PARTIAL RECTANGLE HEAD WILDCAT PRO ALTO TOTAL HA ALTO TOTAL OWENS ASSURE DORNHOFFER ALTO TOTAL W/WINDOWS PRECISE CENTERED TOTAL OFFSET ALTO CONCISE PARTIAL PRECISE OFFSET PARTIAL 0.5MM L DORNHOFFER FOOTPLATE SHOE 2 IN 1 ALTO OFFSET ALTO TOTAL PRECISE BYTE HA FRISBEE PARTIAL PRECISE HA LITE PARTIAL CENTERED ALTO TOTAL W/INTEGRATED SHOE WEDGE INCUS STRUT SHORT HABERMAN ALTO TOTAL ROUND HEAD MORETZ ALTO HA, RIGHT BOJRAB ALTO TOTAL W/INTEGRATED SHOE WILDCAT PRO, 4.50MM L CENTERED NANO ALTO TOTAL MORETZ HA DELTA MINI HEAD ALTO PARTIAL CENTERED ALTO NANO ALTO BYTE BOJRAB ALTO PRE CUT DB TITANIUM STRUT OFFSET ALTO PARTIAL DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS WILDCAT FIXED LENGTH TOTAL, HOLLOW WEDGE INCUS STRUT LONG MORETZ HA DELTA MINI HEAD ALTO TOTAL HA LITE ALTO NYTEBYTE PARTIAL OFFSET DUO ALTO TOTAL W/STAPES ADAPTER BOJRAB ALTO PARTIAL PRECISE HA LITE TOTAL MORETZ ALTO HA, LEFT OFFSET NANO ALTO TOTAL W/INTEGRATED SHOE WILDCAT PRO, 40MM L GLUTH ALTO TOTAL DORNHOFFER PARTIAL 2MM FIXED LENGTH GLUTH ALTO PARTIAL DORNHOFFER PARTIAL W/WINDOWS 2MM FIXED LEGTH PRECISE CENTERED PARTIAL 0.5MM L BOJRAB TOTAL WILDCAT PRO, 30MM L ALTO TOTAL FRISBEE PARTIAL SATALOFF ALTO TOTAL HA LITE ALTO TOTAL PRECISE CENTERED TOTAL 1.50MM L

Establishment Types

Manufacture Medical Device