FDA.reportPublic FDA data

NA

Primary DI
03663136024264
Brand
NA
Company
SPINEVISION
Model
TL1-A010-14
Device description
Template H14
Published
2016-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWTTEMPLATE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWTTemplateOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03663136024264PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03663136024264036631360242643663136024264

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33153332525corp.quality@spinevision.com

Regulatory Flags#

DUNS number
390377518
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03663136009308Hexanium® ACIFAC2-A012-M11L2025-02-20
03663136009315Hexanium® ACIFAC2-A012-M09L2025-02-20
03663136009322Hexanium® ACIFAC2-A012-M07L2025-02-20
03663136009339Hexanium® ACIFAC2-A012-M05L2025-02-20
03663136009346Hexanium® ACIFAC2-A012-S11L2025-02-20
03663136009353Hexanium® ACIFAC2-A012-S09L2025-02-20
03663136009360Hexanium® ACIFAC2-A012-S07L2025-02-20
03663136009384Hexanium® ACIFAC2-A012-L11C2025-02-20
03663136009391Hexanium® ACIFAC2-A012-L09C2025-02-20
03663136009407Hexanium® ACIFAC2-A012-L07C2025-02-20
03663136009414Hexanium® ACIFAC2-A012-L05C2025-02-20
03663136009421Hexanium® ACIFAC2-A012-M11C2025-02-20
03663136009438Hexanium® ACIFAC2-A012-M09C2025-02-20
03663136009445Hexanium® ACIFAC2-A012-M07C2025-02-20
03663136009452Hexanium® ACIFAC2-A012-M05C2025-02-20
03663136009469Hexanium® ACIFAC2-A012-S11C2025-02-20
03663136009476Hexanium® ACIFAC2-A012-S09C2025-02-20
03663136009483Hexanium® ACIFAC2-A012-S07C2025-02-20
03663136009490Hexanium® ACIFAC2-A012-S05C2025-02-20
03663136009261Hexanium® ACIFAC2-A012-L11L2025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00888118131799LEVEL ONE EXTREMITYKLS-Martin L.P.HWT2026-05-25
07640187463460POYA Medial TemplateBonebridge AGHWT2026-05-22
00888118145321PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00888118145338PURE PECTUSKLS-Martin L.P.HWT2026-03-23
00889024706347OSS RS ROT Hinged Knee Provisional 20MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706354OSS RS ROT Hinged Knee Provisional 22MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706361OSS RS ROT Hinged Knee Provisional 14MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706378OSS RS ROT Hinged Knee Provisional 12MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706385OSS RS ROT Hinged Knee Provisional 16MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706392OSS RS ROT Hinged Knee Provisional 18MM Bearing Extended PostZimmer, Inc.HWT2026-03-19
00889024706514REDUCED Z1 STD NECK TRL SZ 10-12Zimmer, Inc.HWT2026-03-19
00889024706521REDUCED Z1 STD NECK TRL SZ 0-9Zimmer, Inc.HWT2026-03-19
04046826472061MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472078MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
04046826472085MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHWT2026-03-19
10885862609588VantageExactech, Inc.HWT2026-03-19
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10885862648044EquinoxeExactech, Inc.HWT2026-03-19
10885862648051EquinoxeExactech, Inc.HWT2026-03-19
10885862648068EquinoxeExactech, Inc.HWT2026-03-19
10885862648075EquinoxeExactech, Inc.HWT2026-03-19
10885862648082EquinoxeExactech, Inc.HWT2026-03-19
10885862659712N/AExactech, Inc.HWT2026-03-19
10885862659729N/AExactech, Inc.HWT2026-03-19
10885862659736N/AExactech, Inc.HWT2026-03-19
10885862659750N/AExactech, Inc.HWT2026-03-19
10885862659767N/AExactech, Inc.HWT2026-03-19
10885862659774N/AExactech, Inc.HWT2026-03-19
10885862659781N/AExactech, Inc.HWT2026-03-19