AccessGUDID - DEVICE: Ogmend® (00810050690058)

GUDID

Device Identifier (DI) Information

Brand Name: Ogmend®
Version or Model: 32-8500L
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOVEN ORTHOPEDIC TECHNOLOGIES LLC

Primary DI Number: 00810050690058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047777323 *Terms of Use

Device Description: The Ogmend® Implant consists of a sterile, single-use, permanently implanted sleeve intended to provide supplemental fixation to restore stability when the screw-to-bone interface becomes mechanically compromised. The Ogmend® Implant is manufactured from PET fibers and provides a helically braided structure that is captured by the screw when the screw is advanced during placement. When inserted into a prepared bone hole, the Ogmend® Implant is designed to use the principles of interference fit, surface area contact, and pressure distribution to secure the screw to the bone and achieve stability at the screw-to-bone interface allowing for subsequent tissue ingrowth to the screw root through the open, braided, mesh architecture. The Large Ogmend® has an inner diameter of 8.5mm and an outer diameter of 9.5mmand can be used with screws ranging in diameter from 6.5mm to 10.5mm. Ogmend® Large Sleeve is supplied at a length of 150mm and is cut intra-operatively to the appropriate length.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
66365	Bone screw fixation sleeve	An implantable tube-like sleeve intended to provide a secure fixing for a bone screw (e.g. orthopaedic, spinal) which has lost purchase due to screw loosening, back out, or breakage. It is inserted into the screw hole so that when a screw is inserted, a mechanical wedge is created as it is tightened. The sleeve is made of a non-bioabsorbable polymer and sleeve size is adjusted/configured intraoperatively. Disposable devices associated with implantation may be supplied with the sleeve.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QVI	Screw Sleeve Bone Fixation Device, Spine

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K233223	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 8.5 Millimeter
Length: 150 Millimeter

Device Record Status

Public Device Record Key: 3e0994b0-077a-4c6c-bd62-83a6790aec0e
Public Version Date: July 29, 2025
Public Version Number: 1
DI Record Publish Date: July 21, 2025