AccessGUDID - DEVICE: Titan™ Total Shoulder System (10381780120377)

GUDID

Device Identifier (DI) Information

Brand Name: Titan™ Total Shoulder System
Version or Model: M9200104815C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MHH-0920-010-4815C
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780120377
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 Titan Modular Total Shoulder Humeral Head has a centric articulating surface. The humeral head may articulate against the natural glenoid bone, if it is of sufficient quality, or against the polyethylene cemented glenoid bone. It is intended for optimal osteotomy coverage and soft tissue balancing.

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?
62467	Surgical soft-tissue manipulation forceps, alligator, reusable	A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSD	PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWS	PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142413	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: .591 in H x 1.946 in dia

Device Record Status

Public Device Record Key: 6019aa56-19c9-4679-aae4-0ad17e858334
Public Version Date: January 25, 2023
Public Version Number: 5
DI Record Publish Date: October 09, 2017