FDA UDI
In Commercial Distribution
🇺🇸 United States
BT LOOP
DI: 03760154008204
·
Model: Adjustable fixation system for ligament reconstruction-Cortical Tunnel Ø5-10mm
·
S.B.M
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BT LOOP
- Primary DI
- 03760154008204
- Version / Model
- Adjustable fixation system for ligament reconstruction-Cortical Tunnel Ø5-10mm
- Catalog Number
- BTBXL01709
- Company Name
- S.B.M
- Labeler DUNS
- 772462123
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-20
- Public Version
- 1
- Public Version Date
- 2023-12-28
- Public Version Status
- New
- Public Device Record Key
- 62046d4a-572f-4643-8a0d-7707e55ce0e0
Device Description
The BT LOOP® adjustable cortical fixation device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction, flip threads, and splicing sutures, designed to be used for ACL reconstruction with a bone-tendon-bone graft. The device is presented on a holder, and is supplied sterile, ready to use.
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45062 | Tendon/ligament bone anchor, non-bioabsorbable | A non-bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)]. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03760154008204 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202193 | 000 |