Longbow Spinal System 85-1545-009X

GUDID 00190837029494

LONGBOW Expandable Lateral Spacer, 9mm x 45mm x 0°

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837029494
NIH Device Record Key351fa1e0-3326-45aa-a254-0b2ccae0ed35
Commercial Distribution StatusIn Commercial Distribution
Brand NameLongbow Spinal System
Version Model Number85-1545-009X
Catalog Number85-1545-009X
Company DUNS183641617
Company NameLife Spine, Inc.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100190837029494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837029494]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-14

On-Brand Devices [Longbow Spinal System]

0019083700591785-1555-715X
0019083700590085-1555-713X
0019083700589485-1555-711X
0019083700588785-1555-709X
0019083700587085-1550-715X
0019083700586385-1550-713X
0019083700585685-1550-711X
0019083700584985-1550-709X
0019083700583285-1555-015X
0019083700582585-1555-013X
0019083700581885-1555-011X
0019083700580185-1555-009X
0019083700579585-1550-015X
0019083700578885-1550-013X
0019083700577185-1550-011X
0019083700576485-1550-009X
00190837061760Modified Hudson Box Cutter, 15mm x 10mm
00190837061753Modified Hudson Box Cutter, 15mm x 8mm
00190837061739Cannula Plunger
00190837061722Modular Trial, 15mm x 16mm
00190837061715Modular Trial, 15mm x 14mm
00190837061692Modular Trial, 15mm x 10mm
00190837061685Modular Trial, 15mm x 9mm
00190837061661Longbow Expandable Trial, 50mm
0019083706158650 x 9mm Housing
00190837061562Longbow Extracting Plunger, Large Chamfer
00190837061548Longbow Controlled Delivery Instrument
0019083706153155mm Expandable Trial
00190837061524Longbow Expandable Trial
0019083706151745mm Expandable Trial
00190837062224Pivoting Arm
00190837062217Pivoting Arm
00190837062200Pivoting Arm
00190837062194Pivoting Arm
00190837062187Pivoting Arm
0019083706217085-1540-012X
00190837062163Screw
00190837062156Pivoting Arm
00190837062149Lordotic Longbow Trial, 15mm
00190837062132Lordotic Longbow Trial, 13mm
00190837062125Lordotic Longbow Trial, 11mm
00190837062118Lordotic Longbow Trial, 9mm
00190837062101Custom Distractor
00190837062095Modified Hudson Shaper, 15mm
0019083706208813mm Plateau - X Shaper
0019083706207111mm Plateau - X Shaper
00190837062064Modified Hudson Shaper, 9mm
001908370620578mm Plateau - X Shaper
001908370620407mm Plateau - X Shaper
00190837062033Modified Hudson Box Cutter, 15mm

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