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ATLAS SPINE INC.

US

Last updated September 17, 2026

Information

Country
US
Address
1555 Jupiter Park Dr Ste 1, JUPITER, FL, 33458
Website
—
LinkedIn
—
Facebook
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Email
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Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3003855635
DUNS Number
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Catalogue (910)

Page 9 of 19
DeviceModel / ReferenceRegistriesClassStatus
Apelo® / Apelo® MIS 1106-01-6525
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-6550
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-4530
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-03-0007
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-77-0000
FDA UDI
Class IActive
HiJAK™ Cervical 2019-09-0008
FDA UDI
Class IIActive
HiJAK™ Cervical 2019-06-0008
FDA UDI
Class IIActive
Verteview® VSS-042-116
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-14-0050
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-03-6530
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-03-0045
FDA UDI
Class IIActive
HiJAK™ Cervical 2019-03-0013
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-03-0040
FDA UDI
Class IIActive
HiJAK™ Cervical 2019-01-0001
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-65-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 2006-64-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 1110-01-7555
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-02-8535
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-7550
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 6910-18-0000
FDA UDI
Class IActive
True Position® True Position®
FDA UDI
Class IIActive
Verteview® VSA-400-068
FDA UDI
Class IIActive
V3™ Segmental Plating System 1121-03-0014
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-03-0085
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-03-6540
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-07-0011
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-10-0065
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-14-01001
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-10-0055
FDA UDI
Class IIActive
HiJAK™ Cervical 2019-04-0014
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 6006-03-0000
FDA UDI
Class IIActive
HiJAK™ Stand Alone 1123-01-0009
FDA UDI
Class IIActive
Stature® STF-009-006
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
HiJAK™ Stand Alone 1123-03-0009
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-02-5540
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Verteview® VSA-200-050
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-09-0010
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-6535
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-02-0011
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-5540
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-52-0000
FDA UDI
Class IActive
HiJAK™ Cervical 1119-10-0010
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jul 26, 2013Z-1616-2016—terminated

The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

Jun 4, 2009Z-2274-2012—terminated

Atlas Spine, Inc. recalled their Apelo Modular Screwdriver, a component of the Apelo Pedicle Screw System Instrumentation, because of complaints received about the tip breaking. If the tip is fractured inside of the modular screw, the tip could become implanted in the body or if the entire screw is removed, it could cause a delay in the surgery.