FDA.reportPublic FDA data

Activa Instrument

Primary DI
E302BII0830B9
Brand
Activa Instrument
Company
Bioretec Oy
Model
B-II-0830B
Catalog number
B-II-0830B
Device description
K-wire Ø0.8 mm, length 300 mm, for 4/5/6 mm interference screw, blunt ends
Published
2017-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E302BII0830B9PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length300Millimeter
Width0.8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+358207789500sales@bioretec.com

Regulatory Flags#

DUNS number
368715301
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438394002708Activa InstrumentB-IP-3201B-IP-32012026-03-23
06438394002678Activa InstrumentB-IP-1501B-IP-15012026-03-23
06438394002685Activa InstrumentB-IP-2001B-IP-20012026-03-23
06438394002692Activa InstrumentB-IP-2701B-IP-27012026-03-23
06438394020382Activa InstrumentB-IP-3201B-IP-32012026-03-23
06438394010956Activa InstrumentB-IP-1502B-IP-15022026-03-23
06438394000018ActivaPin™B-AP-1520B-AP-15202026-02-05
06438394000025ActivaPin™B-AP-1530B-AP-15302026-02-05
06438394000032ActivaPin™B-AP-1540B-AP-15402026-02-05
06438394000049ActivaPin™B-AP-1550B-AP-15502026-02-05
06438394000056ActivaPin™B-AP-1560B-AP-15602026-02-05
06438394000063ActivaPin™B-AP-1570B-AP-15702026-02-05
06438394000070ActivaPin™B-AP-2020B-AP-20202026-02-05
06438394000087ActivaPin™B-AP-2030B-AP-20302026-02-05
06438394000094ActivaPin™B-AP-2040B-AP-20402026-02-05
06438394000100ActivaPin™B-AP-2050B-AP-20502026-02-05
06438394000117ActivaPin™B-AP-2060B-AP-20602026-02-05
06438394000124ActivaPin™B-AP-2070B-AP-20702026-02-05
06438394000155ActivaPin™B-AP-2750B-AP-27502026-02-05
06438394000179ActivaPin™B-AP-2770B-AP-27702026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
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10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
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B504SRAR1930S0ArthrexProvisionLXH2026-07-20
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00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17