Home / 510(k) Clearances / K231208

510(k) K231208

Stryker Resorbable Fixation System by Stryker Leibinger GmbH & Co KG — Product Code HBW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 2023
Date Received
April 27, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fastener, Plate, Cranioplasty
Device Class
Class II
Regulation Number
882.5360
Review Panel
NE
Submission Type

Other clearances by Stryker Leibinger GmbH & Co KG

  • K254233 — MEDPOR Customized Implant Kit (March 12, 2026)
  • K253623 — Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Upda (February 19, 2026)
  • K252871 — Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite (February 6, 2026)
  • K243491 — SternalPlate Expansion (December 11, 2024)
  • K241517 — Q Guidance System; Mako Spine System; (August 27, 2024)
  • K241171 — Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CO (July 25, 2024)
  • K240651 — MRI Universal (July 12, 2024)
  • K240662 — Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q I (June 6, 2024)
  • K233542 — Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Or (March 14, 2024)
  • K231599 — Stryker MP, Mandible, HMMF and MMF AXS Screws (August 24, 2023)

Other clearances for product code HBW

  • K251472 — Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsor (July 11, 2025)
  • K171152 — Stryker Universal Neuro III System AXS Screw (May 19, 2017)
  • K151387 — Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Bla (June 24, 2015)
  • K141385 — DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) (March 27, 2015)
  • K101835 — MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 (December 3, 2010)
  • K001353 — MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPL (March 13, 2001)