AccessGUDID - DEVICE: Sage Cervical Interbody Fusion System (B648C205648STP0)

GUDID

Device Identifier (DI) Information

Brand Name: Sage Cervical Interbody Fusion System
Version or Model: C205-648-STP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CURITEVA, INC.

Primary DI Number: B648C205648STP0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 074575332 *Terms of Use

Device Description: 11 and 12 mm x 7° Trial, 18 x 14mm Footprint, with Stop

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?
47807	Surgical implant/trial-implant/sizer holder, reusable	A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181261	000

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
Height: 11 Millimeter
Height: 12 Millimeter
Angle: 7 degree
Width: 18 Millimeter
Depth: 14 Millimeter

Device Record Status

Public Device Record Key: 71b54ca2-f5a2-4065-8b30-1eebc422598d
Public Version Date: January 11, 2024
Public Version Number: 1
DI Record Publish Date: January 03, 2024