Regatta Lateral System 36-231455-15

GUDID 10889981159153

Lateral Implant, 23mm x 14mm x 55mm, 15 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis
Primary Device ID10889981159153
NIH Device Record Keyada8ac20-c647-48d4-9ccf-5271cda17ea6
Commercial Distribution StatusIn Commercial Distribution
Brand NameRegatta Lateral System
Version Model Number36-231455-15
Catalog Number36-231455-15
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com
Phone+1(760)727-8399
Emailcustsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110889981159153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2018-09-15

On-Brand Devices [Regatta Lateral System]

10889987164793Lateral Disc Prep Instrument Tray Case
10889987164786Lateral Disc Prep Instrument Tray Level Bottom
10889987164779Lateral Disc Prep Instrument Tray Level Top
10889987164762Angled Lateral Disc Prep Instrument Tray Case
10889987164755Angled Lateral Disc Prep Instrument Tray Bottom
10889987164748Angled Lateral Disc Prep Instrument Tray Top
10889987163123Lateral Box Cutter, 6x23mm
10889986163117Lateral Box Cutter, 4x23mm
10889981170783Osteophyte Biter
10889981170776Down Biting Curette, Small
10889981163044Trial, 23mm x 16mm x 55mm, 15 Deg
10889981163037Trial, 23mm x 16mm x 55mm, 10 Deg
10889981163013Trial, 23mm x 14mm x 55mm, 15 Deg
10889981163006Trial, 23mm x 14mm x 55mm, 10 Deg
10889981162993Trial, 23mm x 14mm x 55mm, 0 Deg
10889981162986Trial, 23mm x 12mm x 55mm, 15 Deg
10889981162979Trial, 23mm x 12mm x 55mm, 10 Deg
10889981162962Trial, 23mm x 12mm x 55mm, 0 Deg
10889981162955Trial, 23mm x 10mm x 55mm, 15 Deg
10889981162948Trial, 23mm x 10mm x 55mm, 10 Deg
10889981162931Trial, 23mm x 10mm x 55mm, 0 Deg
10889981162924Trial, 23mm x 8mm x 55mm, 10 Deg
10889981162917Trial, 23mm x 8mm x 55mm, 0 Deg
10889981162900Trial, 18mm x 16mm x 55mm, 15 Deg
10889981162894Trial, 18mm x 16mm x 55mm, 10 Deg
10889981162870Trial, 18mm x 14mm x 55mm, 15 Deg
10889981162863Trial, 18mm x 14mm x 55mm, 10 Deg
10889981162856Trial, 18mm x 14mm x 55mm, 0 Deg
10889981162849Trial, 18mm x 12mm x 55mm, 15 Deg
10889981162832Trial, 18mm x 12mm x 55mm, 10 Deg
10889981162825Trial, 18mm x 12mm x 55mm, 0 Deg
10889981162818Trial, 18mm x 10mm x 55mm, 15 Deg
10889981162801Trial, 18mm x 10mm x 55mm, 10 Deg
10889981162795Trial, 18mm x 10mm x 55mm, 0 Deg
10889981162788Trial, 18mm x 8mm x 55mm, 10 Deg
10889981162771Trial, 18mm x 8mm x 55mm, 0 Deg
10889981162764Regatta Instrument Tray Non-Lordotic Trial Caddy
10889981162757Regatta Instrument Tray Wide Trial Caddy
10889981162740Regatta Instrument Tray Narrow Trial Caddy
10889981162733Regatta Instrument Tray Case
10889981162726Regatta Instrument Tray Level Bottom
10889981162719Regatta Instrument Tray Level Top
10889981162702Regatta Instrument Tray
10889981162665Lateral Paddle Shaver, 6mm
10889981162658Lateral Paddle Shaver, 4mm
10889981162641Lateral Box Cutter, 6x23mm, Angled
10889981162634Lateral Box Cutter, 4x23mm, Angled
10889981162627Lateral Box Cutter, 4x18mm, Angled
10889981162610Lateral Box Cutter, 6x18mm
10889981162603Lateral Box Cutter, 4x18mm, Angled
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