AccessGUDID - DEVICE: Titan™ (10381780234975)

GUDID

Device Identifier (DI) Information

Brand Name: Titan™
Version or Model: HRARTHIMP
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780234975
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 942377524 *Terms of Use

Device Description: The Titan Humeral Resurfacing Arthroplasty system is intended for resurfacing of the humeral head due to non-inflammatory or inflammatory arthritis, mild or moderate humeral head deformity and/or limited motion, post-traumatic arthritis, and patients with an intact or reparable rotator cuff. The set includes HRA trials to evaluate the size and fit of the appropriate implant, as well as sizers to determine the amount of bone resection needed for the implant. Instruments are also included to assist with the trials.

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:	Yes
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?
44758	General external orthopaedic fixation system implantation kit, reusable	A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062861	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
Device Size Text, specify: 22.4 in L x 10.8 in W x 6.3 in H

Device Record Status

Public Device Record Key: 4ac868af-0526-4090-a8e7-76bf34a76f8b
Public Version Date: May 02, 2023
Public Version Number: 4
DI Record Publish Date: August 15, 2016