IsoTis® Facet Fusion Instruments 02-9100-001

GUDID 10889981321826

IsoTis® Facet Fusion Instruments

Seaspine Orthopedics Corporation

Orthopaedic surgical procedure kit, non-medicated, single-use
Primary Device ID10889981321826
NIH Device Record Key50799dc2-f133-40f1-b5d6-d543a50f480a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsoTis® Facet Fusion Instruments
Version Model Number02-9100-001
Catalog Number02-9100-001
Company DUNS079840876
Company NameSeaspine Orthopedics Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981321826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-12
Device Publish Date2025-06-04

Devices Manufactured by Seaspine Orthopedics Corporation

10889981322021 - REEF L2025-08-04 M/L Angled Dual Sided Rasp
10889981322045 - REEF L2025-08-04 M/L Angled Cup Curette, Medium, Inferior
10889981322083 - REEF L2025-08-04 M/L Angled Lateral Cobb, Inferior, 23mm
10889981322175 - REEF L2025-08-04 M/L Pituitary, 13in, 3mm
10889981322212 - REEF L2025-08-04 Lateral Paddle Shaver, 6mm
10889981322229 - REEF L2025-08-04 Lateral Paddle Shaver, 8mm
10889981322236 - REEF L2025-08-04 Lateral Paddle Shaver, 10mm
10889981322243 - REEF L2025-08-04 Lateral Paddle Shaver, 12mm

Trademark Results [IsoTis]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISOTIS
ISOTIS
75368805 2678384 Live/Registered
ISOTIS ORTHOBIOLOGICS, INC.
1997-10-06

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.