AccessGUDID - DEVICE: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT (B278IMTRRHMSM0)

GUDID

Device Identifier (DI) Information

Brand Name: JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
Version or Model: imtrrhm/Sm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IMTRRHM-SM
Company Name: ONKOS SURGICAL, INC.

Primary DI Number: B278IMTRRHMSM0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080254074 *Terms of Use
Previous DI: 05060296233778

Device Description: Rotating Hinge Metal-Cased Reamer: Small

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?
45114	Bone-resection orthopaedic reamer, reusable	An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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 [?]
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: 07c8e9cf-8b5f-4c5a-bad6-e998ff320f2b
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024