CoRoent 5141308
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK231735 | Date11 Jul 2023 | StatusActive |
| United States | GUDID listing | Number00887517565785 | Date24 Oct 2015 | StatusListed |
Recalls
No FDA recalls found in the data synced 10 Nov 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CoRoent
- Generic name
- Metallic spinal interbody fusion cage
- Model / reference
- 5141308
- Primary DI / UDI-DI
- 00887517565785
- FDA product code
- MQP, MAX, OVE, ODP, PHM
- GMDN term
- Metallic spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3060, 888.3080
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Overview
AI-generated summary, 10 Nov 2026
CoRoent 5141308 is a metallic spinal interbody fusion cage. This device is the CoRoent Ant TLIF PEEK, 14x11x30mm 8° model. It must be sterilized before use via moist heat or steam sterilization. The device is available by prescription only.
This device is a Class II product. It has received FDA clearance under K071795, K081611, K140659, K141665, K150994, K151472, K153419, K161230, K170961, and K231735. The associated product codes are MQP, MAX, OVE, ODP, and PHM, which fall under regulations 888.3060 and 888.3080.
Other devices from NuVasive, LLC
Questions
AI-generated answers, 10 Nov 2026
What is the CoRoent 5141308?
It is recorded under the GMDN device type "Metallic spinal interbody fusion cage", which GMDN defines as "A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD)". FDA lists it under the product name "Spinal Vertebral Body Replacement Device". It is recorded as Class II.
What are the product code and regulation of the CoRoent 5141308?
FDA records the CoRoent 5141308 under product code MQP and regulation number 888.3060.
Who makes the CoRoent 5141308?
NuVasive, LLC is the manufacturer on record for the CoRoent 5141308.
Properties
Other properties (11)
- Supplied sterile: No
- Single use: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No
- Manufacturing date: No