FDA.reportPublic FDA data

Cortera

Primary DI
00840311208449
Brand
Cortera
Company
Xtant Medical Holdings, Inc.
Model
1505-000250
Device description
Probe, Lumbar, SQ, Curved
Published
2023-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXBPROBE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXBProbeOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311208449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311208449008403112084498403112084490840311208449

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840311224425Cortera Spinal Fixation System150211-553002026-05-18
00840311224432Cortera Spinal Fixation System150211-554002026-05-18
00840311224449Cortera Spinal Fixation System150211-555002026-05-18
00840311224456Cortera Spinal Fixation System150211-556002026-05-18
00840311224463Cortera Spinal Fixation System150211-603002026-05-18
00840311224470Cortera Spinal Fixation System150211-604002026-05-18
00840311224487Cortera Spinal Fixation System150211-605002026-05-18
00840311224494Cortera Spinal Fixation System150211-606002026-05-18
00840311227181Cortera Spinal Fixation System150220-553002026-05-18
00840311227198Cortera Spinal Fixation System150220-554002026-05-18
00840311227204Cortera Spinal Fixation System150220-555002026-05-18
00840311227211Cortera Spinal Fixation System150220-556002026-05-18
00840311227228Cortera Spinal Fixation System150220-603002026-05-18
00840311227235Cortera Spinal Fixation System150220-604002026-05-18
00840311227242Cortera Spinal Fixation System150220-605002026-05-18
00840311227259Cortera Spinal Fixation System150220-606002026-05-18
00840311212767Fortilink-C IBF System65-C-1012-10-6L65-C-1012-10-6L2026-04-30
00840311212774Fortilink-C IBF System65-C-1012-11-6L65-C-1012-11-6L2026-04-30
00840311212798Fortilink-C IBF System65-C-1012-6-6L65-C-1012-6-6L2026-04-30
00840311212804Fortilink-C IBF System65-C-1012-7-6L65-C-1012-7-6L2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640221373045PERLA ® TLSpineArt SAHXB2026-05-07
08800017271095ProbeCorentec Co., LtdHXB2026-04-10
10649111181665Sklar InstrumentsSKLAR CORPORATIONHXB2025-05-29
07640177820631Neo Medical Pedicle Screw SystemNeo Medical SAHXB2023-01-26
07898506815241QuinelatoSchobell Industrial LtdaHXB2023-01-09
07899798204461SchobellSchobell Industrial LtdaHXB2022-12-16
G079C5020010040Golden Isles Pedicle Screw SystemIntelivation, LLCHXB2022-10-26
10649111296673SklarSKLAR CORPORATIONHXB2019-03-19
10649111296932SklarSKLAR CORPORATIONHXB2019-03-19
10649111297120SklarSKLAR CORPORATIONHXB2019-03-19
10649111297496SklarSKLAR CORPORATIONHXB2019-03-19
10649111376351Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111376474Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377655Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111377785Sklar®SKLAR CORPORATIONHXB2019-02-25
10649111255212Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255342Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255502Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111255649Sklar®SKLAR CORPORATIONHXB2019-02-14
10649111176982Sklar®SKLAR CORPORATIONHXB2019-01-24
10649111151477Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111153983Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111155208Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111156847Sklar®SKLAR CORPORATIONHXB2018-11-20
10649111220524Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111220739Sklar®SKLAR CORPORATIONHXB2018-11-08
10649111083389Sklar®SKLAR CORPORATIONHXB2018-10-24
10649111013881Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111018688Sklar®SKLAR CORPORATIONHXB2018-09-14
10649111019470Sklar®SKLAR CORPORATIONHXB2018-09-14