FDA.report

Cortera Spinal Fixation System

Primary DI
00840311242887
Brand
Cortera Spinal Fixation System
Company
Xtant Medical Holdings, Inc.
Model
153002861
Device description
T-HANDLE, SINGLE PIECE, GEN 1 INLINE REDUCER
Published
2024-10-04
Public version status
New
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
LXHOrthopedic manual surgical instrument
NKBThoracolumbosacral pedicle screw system

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840311242887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311242887008403112428878403112428870840311242887

GMDN Terms

TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)886-9354cs@xtantmedical.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

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00840311262854CONTACT ALPC999-0000122026-03-20
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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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