AccessGUDID - DEVICE: Integra® Spider™ Limted Wrist Fusion System (10381780064831)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Spider™ Limted Wrist Fusion System
Version or Model: 072812
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 072812
Company Name: INTEGRA LIFESCIENCES CORPORATION

Primary DI Number: 10381780064831
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 963856096 *Terms of Use

Device Description: The Integra Spider Limited Wrist Fusion bone screw is used in assembly with the plate.

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):	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?
66947	Orthopaedic bone screw (non-sliding)	A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone

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
Special Storage Condition, Specify: Avoid contact with any objects that may damage the surface finish. Store unopened in respective package until use.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.8 mm dia x 14.6 mm L; 12mm thread

Device Record Status

Public Device Record Key: a5b3ff01-10d2-473b-a86b-63cc78f34d61
Public Version Date: February 20, 2025
Public Version Number: 8
DI Record Publish Date: October 09, 2017