SteriSpine CC

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K162531

by Safe Orthopaedics

Identity

Trade Name: STERISPINE CC FDA UDI
Generic Name: Metallic spinal interbody fusion cage FDA UDI
Model / Reference: KITCCS07S FDA UDI

Identifiers

Primary DI / UDI-DI: 03760219913085 FDA UDI
510(k) Number: K162531 FDA 510(k)FDA UDI
FDA Product Code: OVE FDA 510(k)FDA UDI
GMDN Term: Metallic spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 888.3080 FDA 510(k)
Regulation Number: 888.3080 FDA 510(k)FDA UDI
Advisory Committee: Orthopedic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

The SteriSpine CC is a cervical cage system intended for use in spinal surgery. It is a ready-to-use instrumentation system designed for implantation of cervical cages.

The device is supplied sterile and is intended for single-use. It has received FDA 510(k) clearance under product code OVE and decision code SESE, with a decision date of December 29, 2016.

Frequently asked questions

What is the SteriSpine CC used for?

The SteriSpine CC is a cervical cage system intended for use in spinal surgery, specifically designed for the implantation of cervical cages as part of a ready-to-use instrumentation system.

Is the SteriSpine CC supplied sterile and for single-use only?

Yes, the SteriSpine CC is supplied sterile and is intended for single-use, meaning it should be implanted once and then discarded to maintain sterility and patient safety.

What regulatory clearance does the SteriSpine CC have?

The SteriSpine CC has received FDA 510(k) clearance under product code OVE and decision code SESE, with a decision date of December 29, 2016, indicating it is substantially equivalent to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SteriSpine - safe-orthopaedics, Safe Orthopaedics - SPINEMarketGroup, Safe Orthopaedics - medical devices | Medical Devices Directory, Safe Orthopaedics FDA 510 (k) Products (2011-2020)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K162531	Class II	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Safe Orthopaedics

Sources (2)

FDA 510(k) K162531 24 fields · synced Sep 24, 2026
FDA UDI 72de9246-6b27-4ba6-a4e2-09bc313298dc 33 fields · synced May 26, 2026