Ogmend®
GUDID 00810050690058
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.
WOVEN ORTHOPEDIC TECHNOLOGIES LLC
Bone screw fixation sleeve| Primary Device ID | 00810050690058 |
| NIH Device Record Key | 3e0994b0-077a-4c6c-bd62-83a6790aec0e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ogmend® |
| Version Model Number | 32-8500L |
| Company DUNS | 047777323 |
| Company Name | WOVEN ORTHOPEDIC TECHNOLOGIES LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com | |
| Phone | 8602591264 |
| rlaporte@wovenorthopedics.com |
Device Dimensions
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
| Lumen/Inner Diameter | 8.5 Millimeter |
| Length | 150 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050690058 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K233223
FDA Product Code
| QVI | Screw Sleeve Bone Fixation Device, Spine |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
[00810050690058]
Radiation Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-29 |
| Device Publish Date | 2025-07-21 |
On-Brand Devices [Ogmend®]
| 00810050690058 | The Ogmend® Implant consists of a sterile, single-use, permanently implanted sleeve intended to |
| 00810050690041 | The Ogmend® Implant consists of a sterile, single-use, permanently implanted sleeve intended to |
| 00810050690027 | The Ogmend® Inserter Instrument or Inserter is a single use Class I Medical Device tool used to |
Trademark Results [Ogmend]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OGMEND 87176902 5716016 Live/Registered |
Woven Orthopedic Technologies, LLC 2016-09-20 |
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