AccessGUDID - DEVICE: HemiCAP® (M52890800016W0)

GUDID

Device Identifier (DI) Information

Brand Name: HemiCAP®
Version or Model: 9080-0016-W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9080-0016-W
Company Name: ARTHROSURFACE INCORPORATED

Primary DI Number: M52890800016W0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144666109 *Terms of Use

Device Description: 8.0mm x 16mm, Taper Post, MTP CE

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?
33696	Partial metatarsophalangeal joint prosthesis	An implantable artificial substitute for the distal head of the metatarsal or the adjacent phalangeal base, intended to repair an articulating surface of the metatarsophalangeal (MTP) joint of the foot (toe). The device is made of metal or a metal/polymer combination, and may contain hyaluronic acid; implantation may be performed with or without bone cement. The device 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 [?]
K063370	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
Outer Diameter: 8.0 Millimeter

Device Record Status

Public Device Record Key: f7e2f77f-fd7b-4aa8-8694-24a6614d33c3
Public Version Date: February 21, 2022
Public Version Number: 4
DI Record Publish Date: September 15, 2015