AccessGUDID - DEVICE: HemiCAP® (M528P2023020A0)

GUDID

Device Identifier (DI) Information

Brand Name: HemiCAP®
Version or Model: P202-3020-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P202-3020-A
Company Name: ARTHROSURFACE INCORPORATED

Primary DI Number: M528P2023020A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 144666109 *Terms of Use

Device Description: Patello-Femoral, Fem Comp, 3.0x2.0

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?
58992	Partial-resurfacing knee femur prosthesis	A sterile implantable device, in the form of a small plug and stem, designed to treat focal lesions of the articular surface of the distal femur by excision of the lesion and uncemented fixation of the device in the surgically-prepared defect, with retention of the surrounding healthy articular cartilage. It is made of metal, may have a synthetic polymer articulating surface, and may be coated with a material intended to improve fixation and stability by promoting bone ingrowth. It is available in a range of sizes for treatment of different size lesions. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRR	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060127	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: 20 Millimeter

Device Record Status

Public Device Record Key: 470cdc09-1b97-46c1-a0d5-824025c446be
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 20, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 508-520-3003
Email: contact@arthrosurface.com

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