FDA.report

Tech Knee Pack

Primary DI
14053613294574
Brand
Tech Knee Pack
Company
Gebr. Brasseler GmbH & Co. KG
Model
150-00-001
Catalog number
150-00-001
Published
2026-01-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JDWPin, Fixation, Threaded

Product Code Classifications

CodeDeviceSpecialtyClass
JDWPin, Fixation, ThreadedOrthopedic2

Premarket Submissions

SubmissionSupplement
K131264000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K131264000KOMET MEDICAL KIRSCHNER WIRES, STEINMANN PINS AND GUIDE PINS AND SCREWSGebr. Brasseler GmbH & Co. KG2013-07-26HWC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14053613294574PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
317409001
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
24053613265496Steinmann PinSP-80005-00-00SP-80005-00-002026-03-20
24053613296209Bur, tapered, round shank08227100082271002026-03-20
24053613295929Bur, Round, round shank08226780082267802026-03-11
24053613295936Bur, Round, round shank08226790082267902026-03-11
24053613296131Bur, Round, round shank08227000082270002026-03-11
24053613296193Bur, tapered, round shank08227090082270902026-03-11
24053613296803Bur, Round, round shank08227750082277502026-03-11
24053613297121Bur, cylindrical, round shank08228070082280702026-03-11
24053613297190Bur, Egg / egg shaped, round shank08228140082281402026-03-11
24053613297206Bur, Egg / egg shaped, round shank08228150082281502026-03-11
24053613297220Bur, Round, round shank08228170082281702026-03-11
04053613298315Guide Pin Smooth800-05-215800-05-2152026-03-11
84053613294535Guide Pin Smooth800-05-215800-05-2152026-01-30
24053613295721Shannon Recta X-LargaG01 S5330G01 S53302026-01-23
24053613284978Saw Blade5109-098-0435109-098-0432022-12-08
E226048483R18KOMET Root Canal Files17331.654.012.R117331.654.0122026-01-13
14053613294581Tech Ancillary Pack150-00-002150-00-0022026-01-08
24053613294557Guide Drill Pin800-02-508800-02-5082026-01-06
E226007158R18KOMET Root Canal Files17321.654.006.R117321.654.0062025-12-10
E226007159R18KOMET Root Canal Files17321.654.008.R117321.654.0082025-12-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08032909626380ST.A.R. 90 F4CITIEFFE SRLJDW2026-03-17
00888867516441Arthrex®ARTHREX, INC.JDW2026-03-13
08051739535730ST.A.R. 90 F4CITIEFFE SRLJDW2026-03-10
00810184540007Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540014Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540021Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540038Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540045Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540052Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540069Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540076Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540083Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540090Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540304Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540311Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540328Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540335Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540342Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540359Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540366Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540373Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540380Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
00810184540397Meduloc Intramedullary Fracture Fixation (IFF) SystemMEDULOC, LLCJDW2026-01-14
08033201841716ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08033201841723ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08033201841754ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08033201841761ILIZAROV SYSTEMSMEDICALPLASTIC SRLJDW2025-08-20
08059386747391DOLPHIXCITIEFFE SRLJDW2025-04-02
24053613293116Navigation PinGebr. Brasseler GmbH & Co. KGJDW2025-03-28
00840194480307Orthex External Fixation SystemORTHOPEDIATRICS CORP.JDW2025-03-18