FDA.reportPublic FDA data

Cortera

Primary DI
00840311210886
Brand
Cortera
Company
Xtant Medical Holdings, Inc.
Model
1505-003100
Device description
Tower Removal Tool, MIS, Rescue
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
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311210886PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311210886008403112108868403112108860840311210886

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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

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