Ogmend®
GUDID 00810050690027
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.
WOVEN ORTHOPEDIC TECHNOLOGIES LLC
Bone screw fixation sleeve| Primary Device ID | 00810050690027 |
| NIH Device Record Key | dd679913-006e-415a-b59a-ef9fa50cf58f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ogmend® |
| Version Model Number | 50-1003 |
| Company DUNS | 047777323 |
| Company Name | WOVEN ORTHOPEDIC TECHNOLOGIES LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | false |
| 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
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
| Outer Diameter | 0.08 Inch |
| Length | 8 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810050690027 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223075
FDA Product Code
| QVI | Screw Sleeve Bone Fixation Device, Spine |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
Radiation Sterilization
[00810050690027]
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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