AccessGUDID - DEVICE: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (B278IMHAM0)

GUDID

Device Identifier (DI) Information

Brand Name: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Version or Model: imham
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IMHAM
Company Name: ONKOS SURGICAL, INC.

Primary DI Number: B278IMHAM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080254074 *Terms of Use
Previous DI: 05060296233631

Device Description: Hammer

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:	No
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?
32312	Surgical mallet	A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRO	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092138	000
K133152	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
No Device Sizes

Device Record Status

Public Device Record Key: 0b16a01e-9e9b-4a63-b3be-05b3204d6b1e
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024