FDA UDI
In Commercial Distribution
🇺🇸 United States
Ogmend®
DI: 00810050690027
·
Model: 50-1003
·
WOVEN ORTHOPEDIC TECHNOLOGIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ogmend®
- Primary DI
- 00810050690027
- Version / Model
- 50-1003
- 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
- dd679913-006e-415a-b59a-ef9fa50cf58f
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
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 | 00810050690027 | GS1 |
Customer Contacts
- Phone
- 8602591264
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223075 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.080 | Inch | |
| Length | 8.0 | Inch |