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Ogmend®

FDA UDI

Class II (US FDA UDI)

by Woven Orthopedic Technologies, LLC

Identity

Trade Name
Ogmend® FDA UDI
Generic Name
Bone screw fixation sleeve FDA UDI
Device Name
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 a 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 Medum Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm and can be used with screws ranging in diameter from 3.5mm to 6.5mm. Ogmend® Medium Sleeve is supplied at a length of 100mm and is cut intra-operatively to the appropriate length. FDA UDI
Model / Reference
32-6500M FDA UDI
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 a 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 Medum Ogmend® has an inner diameter of 6.5mm and an outer diameter of 7.5mm and can be used with screws ranging in diameter from 3.5mm to 6.5mm. Ogmend® Medium Sleeve is supplied at a length of 100mm and is cut intra-operatively to the appropriate length. FDA UDI

Identifiers

Primary DI / UDI-DI
00810050690041 FDA UDI
510(k) Number
K223075 FDA UDI
FDA Product Code
QVI FDA UDI
GMDN Term
Bone screw fixation sleeve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3043 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 6.5 Millimeter FDA UDI
Length — 100 Millimeter FDA UDI

Category: Bone screw fixation sleeve

Ogmend® by Woven Orthopedic Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone screw fixation sleeve.

Cleared under the same submission

K223075 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Woven Orthopedic Technologies, LLC

Sources (1)

  • FDA UDI 3f224378-cc64-4f97-bb3f-759114a89da0 36 fields · synced Jun 6, 2026