AccessGUDID - DEVICE: Squadron Lumbar Cage (00811771036637)

GUDID

Device Identifier (DI) Information

Brand Name: Squadron Lumbar Cage
Version or Model: 31-01-320914
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VALORUS SPINE LLC

Primary DI Number: 00811771036637
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080841846 *Terms of Use

Device Description: Squadron Parallel Bullet Nose PLIF Cage, 32mm x 9mm x 14mm

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60762	Polymeric spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

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FDA Product Code

Product Code	Product Code Name
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K171914	000

Sterilization

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

Storage and Handling
No storage/handling found

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Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Customer Contact

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DEVICE: Squadron Lumbar Cage (00811771036637)

Device Identifier (DI) Information

Device Characteristics

GMDN

FDA Product Code

FDA Premarket Submission

Sterilization

Storage and Handling

Clinically Relevant Size

Device Record Status

Alternative and Additional Identifiers Additional Identifiers

Package DI

Secondary DI

Unit of Use DI

Direct Marking (DM)

Production Identifier(s) in UDI

Customer Contact