FDA.reportPublic FDA data

Sequel Medical

Primary DI
00810071321566
Brand
Sequel Medical
Company
Sequel Medical Inc.
Model
IM1600075
Catalog number
IM1600075
Device description
Straight Screw Driver for Set Screws
Published
2021-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDWPin, Fixation, Threaded
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple ComponentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202833000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202833000Sequel External Fixation DeviceSequel Medical, Inc.2021-01-19KTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810071321566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071321566008100713215668100713215660810071321566

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, single-use, non-sterileAn assembly of non-sterile devices designed to stabilize fractured bones to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, pins, bolts, and nuts, as well as some reusable instrumentation (e.g., wrenches, depth gauge, tensioner). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the foot and ankle, joint fusions, and limb lengthening. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
858-863-3826hdang@sequelmd.com

Regulatory Flags#

DUNS number
109935591
Device count
1
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
00810071321894Sequel Medical 201-1001S201-1001S2025-09-18
00810071321900Sequel Medical 201-1002M201-1002M2025-09-18
00810071321917Sequel Medical 201-1003L201-1003L2025-09-18
00810071320729Sequel MedicalIM50000020IM500000202021-02-16
00810071320736Sequel MedicalIM50000025IM500000252021-02-16
00810071320743Sequel MedicalIM50000030IM500000302021-02-16
00810071320750Sequel MedicalIM50000035IM500000352021-02-16
00810071320767Sequel MedicalIM50000040IM500000402021-02-16
00810071320774Sequel MedicalIM60000020IM600000202021-02-16
00810071320781Sequel MedicalIM60000025IM600000252021-02-16
00810071320798Sequel MedicalIM60000030IM600000302021-02-16
00810071320804Sequel MedicalIM60000035IM600000352021-02-16
00810071320811Sequel MedicalIM60000040IM600000402021-02-16
00810071321054Sequel MedicalIM12220200AIM12220200A2021-08-16
00810071321061Sequel MedicalIM12220220AIM12220220A2021-08-16
00810071321078Sequel MedicalIM12220240AIM12220240A2021-08-16
00810071321146Sequel Medical200-0002200-00022021-08-16
00810071321153Sequel Medical220-0002220-00022021-08-16
00810071321160Sequel Medical240-0002240-00022021-08-16
00810071321504Sequel MedicalIM1700015IM17000152021-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327616859HOFFMANN LRFStryker GmbHKTT2026-07-23
07613327616880HOFFMANN LRFStryker GmbHKTT2026-07-23
18032568033229Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568033236Surgical InstrumentsORTHOFIX SRLJDW2026-07-23
18032568036008WRIST FIXATION SYSTEMSORTHOFIX SRLJDW2026-07-23
07613327616835HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327616866HOFFMANN LRFStryker GmbHKTT2026-07-21
07613327618501HOFFMANN LRFStryker GmbHJDW2026-07-21
00889795154620Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154637Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154644Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
00889795154651Spider Monkey Bone Transport SystemParagon 28, Inc.KTT2026-06-10
10888867544571Arthrex®ARTHREX, INC.KTT2026-03-13
10886982346872MAXFRAMESynthes GmbHKTT2025-01-29
10886982338778MAXFRAMESYNTHES (U.S.A.) LPKTT2024-02-05
10886982343710MAXFRAMESynthes GmbHKTT2024-01-04
10886982343727MAXFRAMESynthes GmbHKTT2024-01-04
10886982343734MAXFRAMESynthes GmbHKTT2024-01-04
10886982338570MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338587MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338594MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
10886982338600MAXFRAMESYNTHES (U.S.A.) LPKTT2022-04-26
00841132142325eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142905eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132142950eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
00841132143025eZ-FixORTHOPEDIATRICS CORP.KTT2020-02-28
07613327079241HOFFMANNStryker GmbHKTT2018-09-24
07613327079272HOFFMANNStryker GmbHKTT2018-09-24
07613327079333HOFFMANNStryker GmbHKTT2018-09-24
07613327079395HOFFMANNStryker GmbHKTT2018-09-24