FDA.report

Transcend

Primary DI
00190376701097
Brand
Transcend
Company
ALPHATEC SPINE, INC.
Model
833-09382815-S
Device description
TRANSCEND ALIF SA 9 x 38 x 28 mm, 15°
Published
2025-12-08
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
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K251575000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251575000IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine2025-09-03OVD

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190376701097PrimaryGS10

GMDN Terms

TermDefinition
Metal-polymer composite 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 to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated device made of a non-bioabsorbable synthetic polymer with a metallic coating 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 packaged with the cage.

Device Sizes

TypeValueUnit
Angle15degree
Height9Millimeter
Length28Millimeter
Width38Millimeter

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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810141040007Foundation Surgical InstrumentsFOUNDATION SURGICAL GROUP INCOVD2026-03-05
10889981304713MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981304720MeridianSeaspine Orthopedics CorporationOVD2026-03-03
10889981326241REEF LSeaspine Orthopedics CorporationOVD2026-03-03
00840067210710TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210727TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210734TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210741TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210758TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210765TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210772TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210789TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210802TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210819TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210826TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210833TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210840TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210857TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210864TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210871TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210888TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
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00840067210932TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210949TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210956TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20
00840067210963TrellOss®-A SANEXXT SPINE, LLCOVD2026-02-20