AccessGUDID - DEVICE: Integra® Spider™ Limted Wrist Fusion System (10381780064756)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Spider™ Limted Wrist Fusion System
Version or Model: 070006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 070006
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780064756
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2026
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Mini Integra Spider Limited Wrist Fusion stainless steel plate includes six-holes and can be utilized in various locations throughout the wrist.

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?
61689	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile	A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, Fixation, Bone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991873	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
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: .549 in dia x .15 in L

Device Record Status

Public Device Record Key: 5d79d162-3751-41cd-855a-ff40dcc54a73
Public Version Date: February 19, 2024
Public Version Number: 8
DI Record Publish Date: October 09, 2017