FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732165366
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
012.7045
Device description
Driver with Shoulder, Standard
Published
2024-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXXScrewdriver
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121136000RENOIR POSTERIOR CERVIAL FIXATION SYSTEMAccel Spine2012-08-09KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732165366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732165366008417321653668417321653660841732165366

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
214-545-5820schedule@ctlamedica.com

Regulatory Flags#

DUNS number
080138504
Device count
1
Premarket 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
00841732135024MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75002025-03-31
00841732141049MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75022025-03-31
00841732142206GENERIC Surgical Instruments120.75082025-03-31
00841732142213MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75102025-03-31
00841732142220MONDRIAN ALIF Cage with Supplementary Fixation Plate120.75202025-03-31
00841732142237MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76052025-03-31
00841732142244MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76092025-03-31
00841732142251MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76112025-03-31
00841732142268MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76132025-03-31
00841732142275MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76152025-03-31
00841732142282MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76172025-03-31
00841732142299MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76192025-03-31
00841732142305MONDRIAN ALIF Cage with Supplementary Fixation Plate120.76212025-03-31
00841732142312GENERIC Surgical Instruments120.77002025-03-31
00841732142329GENERIC Surgical Instruments120.77012025-03-31
00841732142336GENERIC Surgical Instruments120.77022025-03-31
00841732142343GENERIC Surgical Instruments120.77102025-03-31
00841732142350GENERIC Surgical Instruments120.77202025-03-31
00841732142367GENERIC Surgical Instruments120.77252025-03-31
00841732142374GENERIC Surgical Instruments120.77302025-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157081515ZAVATION SCREWZavation LLCKWP2026-06-04
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00197157081546ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081553ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081560ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081577ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081584ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081591ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081607ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081614ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081621ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081638ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081645ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081652ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081669ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081676ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081683ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081690ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081706ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081713ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081720ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081737ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081744ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081751ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081768ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081775ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081782ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081799ZAVATION SCREWZavation LLCKWP2026-06-04
00197157081805ZAVATION SCREWZavation LLCKWP2026-06-04