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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
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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 4 of 19
DeviceModel / ReferenceRegistriesClassStatus
Apelo® / Apelo® MIS 2006-45-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 6900-16-0550
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-6550
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-09-0005
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-4545
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
HiJAK™ Cervical 2019-08-0007
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-09-0002
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
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-27-0000
FDA UDI
Class IActive
HiJAK™ Cervical 2019-03-0011
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-01-8540
FDA UDI
Class IIActive
Verteview® VSS-042-110
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-09-0010
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Rebar® SCC-001-008
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-03-7540
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-03-7530
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-67-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 1110-01-5530
FDA UDI
Class IIActive
Rebar® SCC-002-007
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-50-0000
FDA UDI
Class IActive
Apelo® / Apelo® MIS 1110-09-0006
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-08-0080
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-26-0000
FDA UDI
Class IActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-08-0030
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-02-5545
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-03-0035
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-16-0060
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1106-01-7535
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-14-0030
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
True Position® True Position®
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-8540
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-6525
FDA UDI
Class IIActive
Verteview® VSA-100-026
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1100-14-0035
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 1110-03-7530
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2010-16-0550
FDA UDI
Class IActive
HiJAK™ Stand Alone 1123-04-0008
FDA UDI
Class IIActive
Apelo® / Apelo® MIS 2006-33-0000
FDA UDI
Class IActive
True Position® True Position®
FDA UDI
Class IIActive
HiJAK™ Stand Alone 1123-01-0008
FDA UDI
Class IIActive
HiJAK™ Cervical 1119-04-0012
FDA UDI
Class IIActive
True Position® True Position®
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.