Identity
- Trade Name
- ResCUBE™ FDA UDI
- Generic Name
- Internal spinal fixation system cable FDA UDI
- Device Name
- The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament FDA UDI
- Model / Reference
- RCBCUBETUU FDA UDI
- Description
- The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760185576109 FDA UDI
- 510(k) Number
- K181799 FDA UDI
- FDA Product Code
- OWI FDA UDI
- GMDN Term
- Internal spinal fixation system cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3010 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
No
FDA UDI
Category: Internal spinal fixation system cable
ResCUBE™ by Cousin Biotech Sas — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
- Songer® Spinal Cable System — Pioneer Surgical Technology, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Cousin Biotech Sas
Sources (1)
- FDA UDI 22e54d1e-203d-48b3-af08-7fceca691f2f 36 fields · synced May 30, 2026