What is FDA product code OLO?

Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.

Equinoxe · Orthopedic Stereotaxic Instrument → Neurology

Name: Equinoxe
Brand: Equinoxe

5manufacturers in China registered for this device type

1catalogue number

2recalls on this code

Who Else Makes It

Concentrated in Jiangsu (2), Shanghai (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OLO
Manufacturer	City	Province	Registered as	Device types
Apex (Guangzhou) Tools & Orthopedics Company	Guangzhou	Guangdong	Contract manufacturer	62
Paragon Medical Device (Changzhou) Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	53
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Zimmer (Shanghai) Medical International Trading Co., Ltd.	Shanghai	Shanghai	Exporter	106
Medtronic (Changzhou) Medical Devices Technology Co., Ltd.	Changzhou	Jiangsu	Manufacturer	53

Record

Regulatory record for Equinoxe
Listed by	Exactech, Inc., United States
FDA product code	OLO
Device type	Orthopedic Stereotaxic Instrument
Device class	Class 2
Regulation	21 CFR 882.4560
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K162567
Record published	2023-03-30
Record revised	2023-05-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Label carries	lot or batch number

Catalogue Numbers

Catalogue numbers for Equinoxe
Catalogue number	Size	Status
SPI-003245		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Valence Robotic Navigation System	Alphatec Spine, Inc.	813
Olympic	Astura Medical	684
Excelsius GPS	Globus Medical, Inc.	383
Orthopedic Stereotaxic Instrument	Medtronic Navigation, Inc.	356
Masada	Astura Medical	335
Excelsiusgps	Globus Medical, Inc.	297
Invictus	Alphatec Spine, Inc.	235
OrthAlign Plus	OrthAlign, Inc.	210
Arvis ®	Kico Knee Innovation Company	174
OMNIBotics	Omni Life Science, Inc.	150
CD Horizon® Spinal System	Medtronic Sofamor Danek, Inc.	137
Navigation Instruments	VB Spine LLC	135

Showing 12 of 1,127. All products under Orthopedic Stereotaxic Instrument

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Equinoxe
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Exactech, Inc.	510(k) number	2017-07-11	Class II	Nonconforming Material/Component	Vix Bit may fracture during use.	41 devices	2021-04-22

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity
2023-06-05	Class II	Process control	The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.	250 devices

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Equinoxe