SURE-LOK (TM) 43-TL-5540

GUDID 00815362021682

Triple Lead Screw 55mmX40mm (qty. 27)

PRECISION SPINE, INC.

Bone-screw internal spinal fixation system, non-sterile

Primary Device ID	00815362021682
NIH Device Record Key	5c49abbc-04d6-4681-9cf7-28b23ea790f1
Commercial Distribution Status	In Commercial Distribution
Brand Name	SURE-LOK (TM)
Version Model Number	6539PS
Catalog Number	43-TL-5540
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	true
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	00815362021682 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141397

FDA Product Code

MNH	Orthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

[00815362021682]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-10-19

On-Brand Devices [SURE-LOK (TM) ]

00815362021880	Triple Lead Screw 5.5mmx45mm (qty. 25)
00815362021842	Triple Lead Screw 6.5mmx40mm (qty. 167)
00815362021811	Triple Lead Screw 5.5mmx40mm (qty. 74)
00815362021798	Triple Lead Screw 6.5mmx45mm (qty. 50)
00815362021774	Triple Lead Screw 5.5mmx50mm (qty. 79)
00815362021767	Triple Lead Screw 5.5mmx45mm (qty. 25)
00815362021750	Triple Lead Screw 5.5mmx45mm (qty. 15)
00815362021712	TRIPLE LEAD SCREW 5.5MMx45mm (QTY: 23)
00815362021699	TRIPLE LEAD SCREW 5.5mmx40mm (qty. 26)
00815362021682	Triple Lead Screw 55mmX40mm (qty. 27)
00815362021675	Triple Lead Screw 5.5mmx35mm (qty. 20)
00815362021668	Triple Lead Screw 6.5mmx40mm (qty. 45)
00815362021644	TRIPLE LEAD SCREW 6.5mmx45 (qty. 83)

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