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AccelFix Spinal Fixation System (Sterile)

by L&K Biomed 1,000+ variants

Ref 1052-60460S, 8114-4535S, 2302-80125S, 8113-5050S, 1068-6060S, 1001-5265S, 1833-6565S, 1051-60520S, 8123-8545S, 1902-5720S, 8113-70115S, 1061-63155S, 8121-5035S, 1061-63480S, 8124-8070S, 1052-6090S, 1051-50510S, 2312-6530S, 2302-8545S, 8121-75120S, 8122-4560S, 2309-7550S, 1908-5250S, 8124-7520S, 1055-6070S, 1068-55130S, 1061-60115S, 1067-50560S, 1055-5590S, 8112-85125S, 1052-50150S, 1812-5262S, 1051-50410S, 1052-6345S, 8123-8075S, 1908-5050S, 1051-60600S, 1051-60570S, 1064-55105S, 8114-7045S, 1061-55280S, 2405-5540S, 8121-80140S, 1052-60500S, 1067-55330S, 1828-6565S, 8124-8060S, 2302-7080S, 8111-4520S, 1908-5015S, 1840-5265S

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08800061337440 Basic UDI-DI Date30 Jun 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
1052-60460S, 8114-4535S, 2302-80125S, 8113-5050S, 1068-6060S, 1001-5265S, 1833-6565S, 1051-60520S, 8123-8545S, 1902-5720S, 8113-70115S, 1061-63155S, 8121-5035S, 1061-63480S, 8124-8070S, 1052-6090S, 1051-50510S, 2312-6530S, 2302-8545S, 8121-75120S, 8122-4560S, 2309-7550S, 1908-5250S, 8124-7520S, 1055-6070S, 1068-55130S, 1061-60115S, 1067-50560S, 1055-5590S, 8112-85125S, 1052-50150S, 1812-5262S, 1051-50410S, 1052-6345S, 8123-8075S, 1908-5050S, 1051-60600S, 1051-60570S, 1064-55105S, 8114-7045S, 1061-55280S, 2405-5540S, 8121-80140S, 1052-60500S, 1067-55330S, 1828-6565S, 8124-8060S, 2302-7080S, 8111-4520S, 1908-5015S, 1840-5265S
Primary DI / UDI-DI
08800061337440, 08800061358339, 08800061629057, 08800061356656, 08800061387421, 08800108623338, 08800061392913, 08800061333121, 08800061621457, 08800061340075, 08800061357325, 08800061365948, 08800061360226, 08800061366310, 08800061623031, 08800061336962, 08800061692495, 08800061331615, 08800061629149, 08800061361209, 08800061361988, 08800061331097, 08800061341812, 08800061622669, 08800061384680, 08800061387339, 08800061365139, 08800108609721, 08800061384499, 08800061356359, 08809649617578, 08800061694543, 08800061692396, 08800061337600, 08800061621242, 08800061342611, 08800061333206, 08800061333176, 08800061385908, 08800061358988, 08800061364651, 08800061623703, 08800061361513, 08800061337488, 08800061369083, 08800061340013, 08800061623017, 08800061628463, 08800061329162, 08800061342543, 08800061695953
Basic UDI-DI
B-08800061337440, B-08800061358339, B-08800061629057, B-08800061356656, B-08800061387421, B-08800108623338, B-08800061392913, B-08800061333121, B-08800061621457, B-08800061340075, B-08800061357325, B-08800061365948, B-08800061360226, B-08800061366310, B-08800061623031, B-08800061336962, B-08800061692495, B-08800061331615, B-08800061629149, B-08800061361209, B-08800061361988, B-08800061331097, B-08800061341812, B-08800061622669, B-08800061384680, B-08800061387339, B-08800061365139, B-08800108609721, B-08800061384499, B-08800061356359, B-08809649617578, B-08800061694543, B-08800061692396, B-08800061337600, B-08800061621242, B-08800061342611, B-08800061333206, B-08800061333176, B-08800061385908, B-08800061358988, B-08800061364651, B-08800061623703, B-08800061361513, B-08800061337488, B-08800061369083, B-08800061340013, B-08800061623017, B-08800061628463, B-08800061329162, B-08800061342543, B-08800061695953
EMDN Code
P09070302, P09070304
Device Class
Class IIb
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000033200
Authorised representative
Obelis s.a. BE-AR-000000106

Related devices

Category: Spinal bone screw, non-bioabsorbable

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Properties

  • Sterile
  • Implantable

Other properties (9)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No