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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 8 of 19
DeviceModel / ReferenceRegistriesClassStatus
HiJAK™ Cervical 1119-07-0012
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-01-7540
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-16-0050
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-4525
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-02-0008
FDA UDI
Class IIActive
V3™ Segmental Plating System 1121-01-0017
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Verteview® VSA-200-048
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-31-0000
FDA UDI
Class IActive
V3™ Segmental Plating System 1121-01-0011
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-02-8545
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-09-0003
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-03-7550
FDA UDI
Class IIActive
Verteview® VSA-200-040
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-6560
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
V3™ Segmental Plating System 1121-04-0012
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-03-0070
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2000-02-0000
FDA UDI
Class IActive
Rebar® SCC-001-014
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-01-8535
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-02-8535
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-8555
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-10-0009
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-81-0450
FDA UDI
Class IActive
True Position® True Position®
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-02-0007
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-01-5530
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-8550
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-6545
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-02-4545
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-16-0450
FDA UDI
Class IActive
Apelo® / Apelo® MIS 1110-03-7535
FDA UDI
Class IIActive
Verteview® VSS-046-016
FDA UDI
Class IIActive
Verteview® VSA-300-072
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-01-7530
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-02-5545
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-02-5540
FDA UDI
Class IIActive
HiJAK™ Cervical 2019-02-0014
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 6906-33-0850
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 6910-24-0850
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-12-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 2010-71-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 1100-05-6672
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-81-0750
FDA UDI
Class IActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-01-0080
FDA UDI
Class IIActive

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Authorities

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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.