Ogmend®
Basic Information
- Brand Name
- Ogmend®
- Primary DI
- 00810050690058
- Version / Model
- 32-8500L
- Company Name
- WOVEN ORTHOPEDIC TECHNOLOGIES LLC
- Labeler DUNS
- 047777323
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-21
- Public Version
- 1
- Public Version Date
- 2025-07-29
- Public Version Status
- New
- Public Device Record Key
- 3e0994b0-077a-4c6c-bd62-83a6790aec0e
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QVI | Screw Sleeve Bone Fixation Device, Spine | Orthopedic | 888.3043 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00810050690058 | GS1 |
Customer Contacts
- Phone
- 8602591264
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233223 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 8.5 | Millimeter | |
| Length | 150 | Millimeter |