AccessGUDID - DEVICE: HemiCAPITATETM (M5288W122217A0)

GUDID

Device Identifier (DI) Information

Brand Name: HemiCAPITATETM
Version or Model: 8W12-2217-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8W12-2217-A
Company Name: ARTHROSURFACE INCORPORATED

Primary DI Number: M5288W122217A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144666109 *Terms of Use

Device Description: 12mm Capitate Component, 22mm x 17mm, Wrist

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?
33706	Carpal lunate prosthesis	A sterile implantable device designed to replace the lunate bone in the proximal carpal row of the wrist typically in the presence of avascular necrosis, localized osteoarthritic changes, or longstanding dislocations. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal), that may reflect the shape of the native bone. Short-term fixation is typically performed with sutures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWN	Prosthesis, Wrist, Carpal Lunate

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141920	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
No Device Sizes

Device Record Status

Public Device Record Key: 6f6372d6-6021-436e-a41c-39a8858e269d
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: April 16, 2018