AccessGUDID - DEVICE: Ogmend® (00810050690027)

GUDID

Device Identifier (DI) Information

Brand Name: Ogmend®
Version or Model: 50-1003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WOVEN ORTHOPEDIC TECHNOLOGIES LLC

Primary DI Number: 00810050690027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 047777323 *Terms of Use

Device Description: The Ogmend® Inserter Instrument or Inserter is a single use Class I Medical Device tool used to insert the Ogmend® Implant into a prepared bone hole during a given procedure. The inserter is a simple rod fabricated from passivated 304 stainless steel (full hard/spring temper) and is 8.0 inches in length, 0.080 inches in diameter with rounded edges on each end. The Inserter is used in conjunction with either size of the Ogmend® Sleeve (Medium & Large) to place the respective sleeve into a prepared bone hole.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	No
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 [?]
K223075	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
Outer Diameter: 0.080 Inch
Length: 8.0 Inch

Device Record Status

Public Device Record Key: dd679913-006e-415a-b59a-ef9fa50cf58f
Public Version Date: July 29, 2025
Public Version Number: 1
DI Record Publish Date: July 21, 2025