AccessGUDID - DEVICE: Sterile Spine Pedicle Screw System (B5627720510)

GUDID

Device Identifier (DI) Information

Brand Name: Sterile Spine Pedicle Screw System
Version or Model: 77.2051
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 77.2051
Company Name: Wishbone Medical, Inc.

Primary DI Number: B5627720510
Issuing Agency: HIBCC
Commercial Distribution End Date: August 27, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 062355158 *Terms of Use

Device Description: Adaptor, Torque Limiting, 1/4 sq., 110 in/lbs.

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?
59009	Orthopaedic implant/instrument assembling device	A non-sterile, noninvasive tool designed to support assembly of the component parts of an orthopaedic implant or surgical instrument during an orthopaedic surgical procedure, typically when component sizes are determined during the procedure [e.g., stem, neck, and head femoral components of a total hip arthroplasty (THA)]. It is available in one of a variety of forms (e.g., holder, clamp/press), however it is not a component of the final instrument/implant and is not a surgical screwdriver or wrench. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 1f8f6e6b-e51f-4a54-845a-f93f0fc96f93
Public Version Date: August 28, 2024
Public Version Number: 3
DI Record Publish Date: February 02, 2023