FDA.reportPublic FDA data

Sequel Medical

Primary DI
00810071321894
Brand
Sequel Medical
Company
Sequel Medical Inc.
Model
201-1001S
Catalog number
201-1001S
Device description
Strut - Short
Published
2025-09-18
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
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
00810071321894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810071321894008100713218948100713218940810071321894

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system noninvasive component, single-useA noninvasive structural component of an external orthopaedic fixation system intended for bone/joint fracture stabilization in conjunction with an invasive bone pin (not included). It is in the form of a full or partial ring, rod (e.g., straight, curved, telescopic), plate, or connector (e.g., screw, bolt, nut, hinge, coupling, fastener); it is not a surgical instrument. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401513290427sam@idealmed.co.uk

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
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
00810071321511Sequel MedicalIM1700017IM17000172021-08-16

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