AccessGUDID - DEVICE: Integra® BioMotion® Cannulated Hemi System (10381780116370)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® BioMotion® Cannulated Hemi System
Version or Model: HM1900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HM1900
Company Name: Ascension Orthopedics, Inc.

Primary DI Number: 10381780116370
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 Integra® BioMotion® Cannulated Hemi implant is used with the Integra® BioMotion® Cannulated Hemi System as a partial joint replacement for the first metatarsophalangeal joint (MPJ). The Cannulated Implants are made from Titanium Alloy (ASTM F-136).

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?
33700	Total metatarsophalangeal joint prosthesis, one-piece	An implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWD	PROSTHESIS, TOE, HEMI-, PHALANGEAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083469	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: 15.27 mm L x 19 mm W x 13 mm H

Device Record Status

Public Device Record Key: de78560a-d7df-42d4-8f43-6e12c737a005
Public Version Date: January 25, 2023
Public Version Number: 5
DI Record Publish Date: October 09, 2017