AccessGUDID - DEVICE: Apollo Knee (05056139250644)

GUDID

Device Identifier (DI) Information

Brand Name: Apollo Knee
Version or Model: TKR.KT.1300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CORIN LTD

Primary DI Number: 05056139250644
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 295437313 *Terms of Use

Device Description: ApolloKnee Tracker and Pin Kit

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?
65388	Surgical optical-tracking spatial marker, single-use	A non-powered, noninvasive component of a surgical navigation and/or device tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spatial registration/tracking of the position/movement/size of a patient, another marker and/or surgical instrument (e.g., stereotactic surgery probe). It may be attached to the patient, another marker or surgical instrument, and may contain features (e.g., reflective spheres, contrast patterns) detectable by a tracking camera. Procedural supportive devices (e.g., drapes) may be included with the device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLO	Orthopedic Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K231172	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: 7fd38a6c-b34c-4ef6-b67a-c0d89a6fddad
Public Version Date: April 15, 2025
Public Version Number: 1
DI Record Publish Date: April 07, 2025

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: +4401285649231
Email: customersupport@coringroup.com

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