FDA.report

Transcend NanoTec

Primary DI
00190376700786
Brand
Transcend NanoTec
Company
ALPHATEC SPINE, INC.
Model
140-PRO-11092220-S
Device description
Transcend NanoTec PS PEEK Spacer, 11 x 9 x 22 mm, 20°
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PHMIntervertebral fusion device with bone graft, thoracic

Product Code Classifications

CodeDeviceSpecialtyClass
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions

SubmissionSupplement
K241375000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241375000IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec CerAlphatec Spine2025-02-03MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376700786PrimaryGS10

GMDN Terms

TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes

TypeValueUnit
Angle20degree
Height11Millimeter
Length22Millimeter
Width9Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags

DUNS number
602465783
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190376509747SafeOp 3AIX118142026-03-24
00840180539521General InstrumentsCI-11843-082025-10-17
00840180541173General InstrumentsCI-11872-1002025-10-17
00840180541180General InstrumentsCI-11872-2002025-10-17
00840180541197General InstrumentsCI-11872-3002025-10-17
00840180541203General InstrumentsCI-11872-4002025-10-17
00190376633428Valence Robotic Navigation System525-10202026-02-26
00190376633435Valence Robotic Navigation System525-10302026-02-26
00190376633442Valence Robotic Navigation System525-1050-0952026-02-26
00190376633459Valence Robotic Navigation System525-1050-1252026-02-26
00190376633466Valence Robotic Navigation System525-1050-1502026-02-26
00190376633473Valence Robotic Navigation System525-10702026-02-26
00190376633480Valence Robotic Navigation System525-10902026-02-26
00190376633497Valence Robotic Navigation System525-10912026-02-26
00190376633503Valence Robotic Navigation System525-11002026-02-26
00190376633510Valence Robotic Navigation System525-11012026-02-26
00190376633527Valence Robotic Navigation System525-11102026-02-26
00190376633534Valence Robotic Navigation System525-10402026-02-26
00190376634340Valence Robotic Navigation System525-10412026-02-26
00190376643670Valence Robotic Navigation System525-10602026-02-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10889981326258REEF LSeaspine Orthopedics CorporationPHM2026-03-03
00190376694375IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376694399IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376694412IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376721873IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376721880IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376721972IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376721989IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722016IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722061IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722115IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722177IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722191IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722207IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
00190376722221IdentiTi IIALPHATEC SPINE, INC.PHM2026-02-18
10889981425753Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981426248Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981426675Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981426804Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437817Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437824Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437831Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437848Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437879Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437893Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437909Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981437978Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981438043Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981438050Reef LSeaspine Orthopedics CorporationPHM2026-01-30
10889981438104Reef LSeaspine Orthopedics CorporationPHM2026-01-30