FDA.reportPublic FDA data

Fortis ACP

Primary DI
08800039802109
Brand
Fortis ACP
Company
DIOMEDICAL CO.,LTD.
Model
A
Catalog number
TP.IN.0011
Device description
A-O Quick Connect Handle, Swivel
Published
2019-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173099000Fortis and Hana Anterior Cervical Plate SystemHuvexel Co. , Ltd.2017-11-30KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039802109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039802109088000398021098800039802109

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+82313699470info@huvexel.com

Regulatory Flags#

DUNS number
557795909
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039800754Hana ACPAUP.IN.00052019-02-08
08800039802024Fortis ACPATP.IN.00032019-02-08
08800039829991Fortis ACPATPA.PL.01102019-07-19
08800039830003Fortis ACPATPA.PL.01122019-07-19
08800039830010Fortis ACPATPA.PL.01142019-07-19
08800039830027Fortis ACPATPA.PL.01162019-07-19
08800039830034Fortis ACPATPA.PL.01182019-07-19
08800039830041Fortis ACPATPA.PL.01202019-07-19
08800039830058Fortis ACPATPA.PL.02262019-07-19
08800039830065Fortis ACPATPA.PL.02282019-07-19
08800039830072Fortis ACPATPA.PL.02302019-07-19
08800039830089Fortis ACPATPA.PL.02322019-07-19
08800039830096Fortis ACPATPA.PL.02342019-07-19
08800039830102Fortis ACPATPA.PL.03432019-07-19
08800039830119Fortis ACPATPA.PL.03462019-07-19
08800039830126Fortis ACPATPA.PL.03492019-07-19
08800039830133Fortis ACPATPA.PL.03522019-07-19
08800039830140Fortis ACPATPA.PL.03552019-07-19
08800039830157Fortis ACPATPA.PL.03582019-07-19
08800039830188Fortis ACPATPA.PL.01222019-07-19

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00810017916498Saber-CELEVATION SPINE, INC.KWQ2026-07-07
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00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
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