FDA UDI
In Commercial Distribution
🇺🇸 United States
FibFix
DI: 00840124517776
·
Model: TN-FN-8000-S
·
FUSION ORTHOPEDICS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FibFix
- Primary DI
- 00840124517776
- Version / Model
- TN-FN-8000-S
- Catalog Number
- TN-FN-8000-S
- Company Name
- FUSION ORTHOPEDICS, LLC
- Labeler DUNS
- 080307067
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-09
- Public Version
- 1
- Public Version Date
- 2026-04-17
- Public Version Status
- New
- Public Device Record Key
- d7473ebb-22ce-45e0-9e42-9af1a244f8d4
Device Description
Tissue Protector (Sterile)
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QAC | Screw Sleeve Bone Fixation Device | 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 | 00840124517776 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252961 | 000 |