FDA.report

TALOS®-A

Primary DI
07640375237606
Brand
TALOS®-A
Company
SpineArt SA
Model
3-21320-25
Catalog number
3-21320-25
Device description
TALOS®-A (HA) PEEK PLANAR, SYMMETRIC IBFD D24 W33 H20 25°
Published
2025-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640375237606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640375237606076403752376067640375237606

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
483016148
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
07640221373359PERLA ® TLTLF-IN 36 10-NTLF-IN 36 10-N2026-02-09
07640221373366PERLA ® TLTLF-IN 36 00-NTLF-IN 36 00-N2026-02-09
07640221373373PERLA ® TLTLF-IN 05 60-NTLF-IN 05 60-N2026-02-09
07640221373380PERLA ® TLTLF-IN 05 70-NTLF-IN 05 70-N2026-02-09
07640151082482ROMEO 2 MISMIS-IN 04 01-NMIS-IN 04 01-N2026-02-05
07640151082499ROMEO 2 MISMIS-IN 05 01-NMIS-IN 05 01-N2026-02-05
07640332477854PERLA ®SPE-IN 01 63-NSPE-IN 01 63-N2026-02-05
07640375236081Cure OPEL-C1100-950-001100-950-002026-02-05
07640450868879PERLA ® TL MIS NAVNAV-BX 30 20-NNAV-BX 30 20-N2026-02-05
07640450866479BAGUERA CLID-BX 04 00-NLID-BX 04 00-N2026-01-30
07640332471548PERLA ® TLTLF-IN 23 60-NTLF-IN 23 60-N2026-01-05
07640185349650PERLA ® TLTLF-IN 13 30-NTLF-IN 13 30-N2025-11-20
07640270064178CURE ACP7-00001-187-00001-182025-11-20
07640270064192CURE ACP7-00001-207-00001-202025-11-20
07640270064215CURE ACP7-00001-227-00001-222025-11-20
07640270064239CURE ACP7-00001-247-00001-242025-11-20
07640270064291CURE ACP7-00001-307-00001-302025-11-20
07640270064345CURE ACPS1-7-00001-20S1-7-00001-202025-11-20
07640270064475CURE ACP7-00002-307-00002-302025-11-20
07640270064499CURE ACP7-00002-327-00002-322025-11-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00840283403187LumiVy™VY SPINE LLCMAX2026-03-24
00840283403194LumiVy™VY SPINE LLCMAX2026-03-24
00840283403200LumiVy™VY SPINE LLCMAX2026-03-24
00840283403217LumiVy™VY SPINE LLCMAX2026-03-24
00840283403224LumiVy™VY SPINE LLCMAX2026-03-24
06009527200096TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200102TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200119TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200126TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200133TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200140TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200157TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200164TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200218TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200225TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200232TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200249TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200256TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
06009527200263TLIF SOUTHERN MEDICAL (PTY) LTDMAX2026-03-20
03662663130929Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663130936Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
03662663131117Zyston Interbody Spacer SystemHighridge Medical, LLCMAX2026-03-17
04052536018192pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018208pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018215pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018222pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018239pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018246pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018253pezoUlrich GmbH & Co. KGMAX2026-03-16
04052536018260pezoUlrich GmbH & Co. KGMAX2026-03-16