FDA.report

Cortera

Primary DI
00840311208487
Brand
Cortera
Company
Xtant Medical Holdings, Inc.
Model
1505-000500
Device description
Probe, Lumbar, SQ, Curved, MT
Published
2023-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HXBPROBE

Product Code Classifications

CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840311208487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311208487008403112084878403112084870840311208487

GMDN Terms

TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags

DUNS number
081224143
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840311262854CONTACT ALPC999-0000122026-03-20
00840311233007CONTACT ALP Anterior Lumbar Plate System25-PUSHPIN25-PUSHPIN2025-10-02
00840311233014CONTACT ALP Anterior Lumbar Plate System25-PUSHPIN-252025-10-02
M697X00310040Calix-C Cervical Interbody SpacerX003-10042026-03-10
M697X03422130Calix Lumbar Spinal Implant SystemX034-22132026-03-10
00840311262694CASE, OUTER, DOUBLE LEVEL434-2222026-02-11
00840311262700CASE, OUTER, LID 434-2242026-02-11
00840311247318Fortilink65-TC-INSERTER2026-01-22
00840311262670Cortera Spinal Fixation System1509-0300202025-12-22
00840311262687Cortera Spinal Fixation System1509-0400102025-12-22
00840311262663Streamline TL Spinal Fixation System02-PA-L-85CDY-E2025-12-17
00840311262632Fusion™ Posterior Instrument Set30-FUNNEL2025-12-11
00840311244713Cortera Spinal Fixation System1509-4000102025-12-10
00840311244720Cortera Spinal Fixation System1509-4000202025-12-10
00840311244737Cortera Spinal Fixation System1509-4000302025-12-10
00840311244744Cortera Spinal Fixation System1509-4000402025-12-10
00840311252237Cortera Spinal Fixation System1505-0017012025-11-20
00840311252244Cortera Spinal Fixation System1505-0017022025-11-20
00840311252251Cortera Spinal Fixation System1505-0017112025-11-20
00840311252268Cortera Spinal Fixation System1505-0017122025-11-20

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10888857578197Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578203Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578630Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578647Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578654Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578661Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578678Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578685Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578692Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
10888857578708Vulcan™ Spinal SystemK2M, INC.HXB2026-02-20
03662663131551Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131568Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
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03662663131599Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131605Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
03662663131612Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHXB2026-02-11
00860014213458Introducer ProbeTETROUS, INC.HXB2026-02-10
00860014213472Pusher ProbeTETROUS, INC.HXB2026-02-10
00860014213496Introducer Probe - SJTETROUS, INC.HXB2026-02-10
00810158218833PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218840PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218857PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
00810158218864PRINCETONPrinceton Medical Group, Inc.HXB2026-02-05
10889981441531SpecialsSeaspine Orthopedics CorporationHXB2026-01-30
00840180544013General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29
00840180545188General InstrumentsALPHATEC SPINE, INC.HXB2026-01-29