FDA.reportPublic FDA data

GENERIC Surgical Instruments

Primary DI
00841732163966
Brand
GENERIC Surgical Instruments
Company
CTL Medical Corporation
Model
50-2001-065
Device description
Tap, Double Lead, Cannulated, 6.5
Published
2024-10-02
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
HWXTap, Bone
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162160000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162160000Preference Elite Pedicle Screw SystemAmedica Corporation2016-11-18NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841732163966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732163966008417321639668417321639660841732163966

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
00841732163447VALEO C Spacer System91.002.40012023-09-30
00841732163454VALEO C Spacer System91.002.40022023-09-30
00841732163461VALEO C Spacer System91.002.40032023-09-30
00841732128231VALEO VBR91.009.56512023-09-27
00841732128248VALEO VBR91.009.56522023-09-27
00841732145511VALEO C+CSC with Lumen Interbody Fusion Device11.209.17072023-09-19
00841732145528VALEO C+CSC with Lumen Interbody Fusion Device11.209.17082023-09-19
00841732145535VALEO C+CSC with Lumen Interbody Fusion Device11.209.17092023-09-19
00841732145542VALEO C+CSC with Lumen Interbody Fusion Device11.209.17102023-09-19
00841732154766VALEO C+CSC with Lumen Interbody Fusion Device11.209.11082023-09-19
00841732154773VALEO C+CSC with Lumen Interbody Fusion Device11.209.11092023-09-19
00841732154780VALEO C+CSC with Lumen Interbody Fusion Device11.209.11102023-09-19
00841732154797VALEO C+CSC with Lumen Interbody Fusion Device11.209.11112023-09-19
00841732154803VALEO C+CSC with Lumen Interbody Fusion Device11.209.17052023-09-19
00841732154810VALEO C+CSC with Lumen Interbody Fusion Device11.209.17062023-09-19
00841732154865VALEO C+CSC with Lumen Interbody Fusion Device11.209.17112023-09-19
00841732149847TAURUS Pedicle Screw System51-1000-0012023-09-15
00841732149854TAURUS Pedicle Screw System51-1000-0022023-09-15
00841732150614GENERIC Surgical Instruments50-1000-0042023-09-15
00841732150621TAURUS Pedicle Screw System51-0000-0002023-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935578PER Trial 60PREMIA SPINE LTDNKB2026-07-22
07290115935691PER Trial 50PREMIA SPINE LTDNKB2026-07-22
00840466901035PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.NKB2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.NKB2026-07-21