Interspinous Plate System 29-MP-5035

GUDID 00815362022740

Reli™ SP Plus 35mm Male Plate

PRECISION SPINE, INC.

Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable Spinal bone screw, non-bioabsorbable

Primary Device ID	00815362022740
NIH Device Record Key	ef96ffb6-711c-4f41-ae66-91077224a71f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Interspinous Plate System
Version Model Number	29-MP-5035
Catalog Number	29-MP-5035
Company DUNS	079398589
Company Name	PRECISION SPINE, INC.
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815362022740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K160568

FDA Product Code

PEK	Spinous Process Plate

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

[00815362022740]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-04-12
Device Publish Date	2019-04-04

On-Brand Devices [Interspinous Plate System]

00815362022115	55mm Interspinous Female Plate
00815362022108	50mm Interspinous Female Plate
00815362022092	45mm Interspinous Female Plate
00815362022085	40mm Interspinous Female Plate
00815362022078	35mm Interspinous Female Plate
00815362022061	55mm Interspinous Male Plate
00815362022054	50mm Interspinous Male Plate
00815362022047	45mm Interspinous Male Plate
00815362022030	40mm Interspinous Male Plate
00815362022023	35mm Interspinous Male Plate
00815362022603	Self Drilling Ø4.0mm Fixed Screw 12mm
00815362022597	Self Drilling Ø4.0mm Fixed Screw 10mm
00815362022580	Self Drilling Ø4.5mm Variable Screw 20mm
00815362022573	Self Drilling Ø4.5mm Variable Screw 18mm
00815362022566	Self Drilling Ø4.5mm Variable Screw 16mm
00815362022559	Self Drilling Ø4.5mm Variable Screw 14mm
00815362022542	Self Drilling Ø4.5mm Variable Screw 12mm
00815362022535	Self Drilling Ø4.5mm Variable Screw 10mm
00815362022528	Self Drilling Ø4.0mm Variable Screw 20mm
00815362022511	Self Drilling Ø4.0mm Variable Screw 18mm
00815362022504	Self Drilling Ø4.0mm Variable Screw 16mm
00815362022498	Self Drilling Ø4.0mm Variable Screw 14mm
00815362022481	Self Drilling Ø4.0mm Variable Screw 12mm
00815362022474	Self Drilling Ø4.0mm Variable Screw 10mm
00815362022450	AIO Final Tightener
00815362022443	AIO Cap Screw Inserter
00815362022436	All In One Inserter
00815362022429	30mm Trial
00815362022412	28mm Trial
00815362022405	30mm Interspinous Female Plate
00815362022399	Reli™ SP 30mm Interspinous Male Plate
00815362022382	Reli™ SP 28mm Interspinous Female Plate
00815362022375	Reli™ SP 28mm Interspinous Male Plate
00815362022351	ISP Retractor Sterilization Case
00815362022337	ISP Sterilization Case
00815362022320	Straight Plate Holder
00815362022313	Plate Holder
00815362022306	90mm Caspar Sleeve
00815362022290	75mm Caspar Sleeve
00815362022283	Caspar Pin Driver
00815362022276	Caspar Retractor
00815362022269	10mm Drill
00815362022252	Parallel Compressor
00815362022245	55mm Trial
00815362022238	50mm Trial
00815362022221	45mm Trial
00815362022214	40mm Trial
00815362022207	35mm Trial
00815362022191	Tissue Awl
00815362022184	Counter Torque

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