Identity
- Trade Name
- RIGIDLOOP FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use. FDA UDI
- Model / Reference
- BTB Adjustable Cortical System - Standard FDA UDI
- Description
- The RIGIDLOOP device consists of an adjustable nonabsorbable braided loop and titanium button, preloaded with traction threads, designed to be used for ACL reconstruction. The implant is supplied sterile, ready to use. FDA UDI
Identifiers
- Catalog Number
- 232485 FDA UDI
- Primary DI / UDI-DI
- 03760304680212 FDA UDI
- 510(k) Number
- K202193 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Rigidloop by S.b.m — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tendon/ligament bone anchor, non-bioabsorbable.
- Hi-Fi — Conmed Corporation · Class II
- FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
- Ecobone — Bonegraft Biomaterials Co. · Class III
- fX — Bonegraft Biomaterials Co. · Class III
- GII PANACRYL — DePuy Mitek, Inc. · Class II
- Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
- SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
- JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- S.b.m
Sources (1)
- FDA UDI c3f58de7-bdda-497e-8896-f61760bf0a27 36 fields · synced May 29, 2026