FDA.report

ActivaPin™

Primary DI
06438394000049
Company
Bioretec Oy
Model
B-AP-1550
Catalog number
B-AP-1550
Device description
ActivaPin™ 1.5 mm x 50 mm
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
368715301
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
E302BAP15509PreviousHIBCC0
06438394000049PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
E302BAP15509PreviousHIBCC0
06438394000049PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HTYPin, Fixation, Smooth2Orthopedic888.3040YEligible

Premarket Submissions

SubmissionSupplement
K080879000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K080879000ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMBioretec, Ltd.2008-06-24HTY

GMDN Terms

TermDefinition
Orthopaedic bone pin, bioabsorbableA device in the form of a small diameter rod intended to be used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis, in the presence of additional immobilization. The rod may be smooth or partially threaded. The device is made of a material that is chemically degraded and typically absorbed by natural body processes (e.g., degradable polymers such as polydioxanone or polyglycolide). This is a single-use device.

Device Sizes

TypeValueText
Length50 Millimeter
Width1.5 Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+358207789500sales@bioretec.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
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
06438394000216ActivaPin™B-AP-3270B-AP-32702026-02-05
06438394000230Activa InstrumentB-IP-2000B-IP-20002026-02-05

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00888867543294Arthrex®ARTHREX, INC.HTY2026-03-13
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00888867543324Arthrex®ARTHREX, INC.HTY2026-03-13
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00888867543683Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543812Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543829Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543850Arthrex®ARTHREX, INC.HTY2026-03-13
00888867543874Arthrex®ARTHREX, INC.HTY2026-03-13
24026704912432KMEDICTELEFLEX INCORPORATEDHTY2026-02-06
06438394000018ActivaPin™Bioretec OyHTY2026-02-05
06438394000025ActivaPin™Bioretec OyHTY2026-02-05
06438394000032ActivaPin™Bioretec OyHTY2026-02-05
06438394000056ActivaPin™Bioretec OyHTY2026-02-05
06438394000063ActivaPin™Bioretec OyHTY2026-02-05
06438394000070ActivaPin™Bioretec OyHTY2026-02-05
06438394000087ActivaPin™Bioretec OyHTY2026-02-05
06438394000094ActivaPin™Bioretec OyHTY2026-02-05
06438394000100ActivaPin™Bioretec OyHTY2026-02-05
06438394000117ActivaPin™Bioretec OyHTY2026-02-05