AccessGUDID - DEVICE: ALEUTIAN® Interbody Systems (10888857421080)

GUDID

Device Identifier (DI) Information

Brand Name: ALEUTIAN® Interbody Systems
Version or Model: SP-3140
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SP-3140
Company Name: K2M, INC.

Primary DI Number: 10888857421080
Issuing Agency: GS1
Commercial Distribution End Date: May 23, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 146060863 *Terms of Use

Device Description: Angled Lateral Inserter Size 25°

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:	No
Prescription Use (Rx):	Yes
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?
13180	Orthopaedic prosthesis implantation positioning instrument, reusable	A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral fusion device with bone graft, cervical
MAX	Intervertebral fusion device with bone graft, lumbar
MQP	Spinal vertebral body replacement device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 25 degree

Device Record Status

Public Device Record Key: bce888dd-f9b7-4656-8170-2722daace9b2
Public Version Date: May 24, 2024
Public Version Number: 4
DI Record Publish Date: October 23, 2018