Company ยท DE
Stryker Leibinger GmbH & Co. KG
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2026. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (4 in 12 months)
28recalls (1 in 12 months)
26recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | 20 |
| OLO | Orthopedic Stereotaxic Instrument | 10 |
| HRS | Plate, Fixation, Bone | 6 |
| JEY | Plate, Bone | 5 |
| HAW | Neurological Stereotaxic Instrument | 3 |
| FWP | Prosthesis, Chin, Internal | 2 |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | 2 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 |
| GXP | Methyl Methacrylate For Cranioplasty | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 |
| DZL | Screw, Fixation, Intraosseous | 1 |
| FTM | Mesh, Surgical | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 |
| HBW | Fastener, Plate, Cranioplasty | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 |
| IYE | Accelerator, Linear, Medical | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| LZD | Joint, Temporomandibular, Implant | 1 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2026 | K261054 | RibPlate System Stryker Leibinger GmbH & Co KG, DE | HRS |
| Mar 12, 2026 | K254233 | MEDPOR Customized Implant Kit Stryker Leibinger GmbH & Co KG, DE | FWP |
| Feb 19, 2026 | K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Stryker Leibinger GmbH & Co KG, DE | OLO |
| Feb 6, 2026 | K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories Stryker Leibinger GmbH & Co KG, DE | OLO |
| Dec 11, 2024 | K243491 | SternalPlate Expansion Stryker Leibinger GmbH & Co KG, DE | HRS |
| Aug 27, 2024 | K241517 | Q Guidance System; Mako Spine System; Stryker Leibinger GmbH & Co KG, DE | OLO |
| Jul 25, 2024 | K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Dri Stryker Leibinger GmbH & Co KG, DE | OLO |
| Jul 12, 2024 | K240651 | MRI Universal Stryker Leibinger GmbH & Co KG, DE | JEY |
| Jun 6, 2024 | K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedi Stryker Leibinger GmbH & Co KG, DE | OLO |
| Mar 14, 2024 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q G Stryker Leibinger GmbH & Co KG, DE | OLO |
| Aug 24, 2023 | K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws Stryker Leibinger GmbH & Co KG, DE | DZL |
| Aug 14, 2023 | K231208 | Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co KG, DE | HBW |
| Aug 5, 2023 | K230733 | Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co KG, DE | JEY |
| Feb 13, 2023 | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ort Stryker Leibinger GmbH & Co KG, DE | OLO |
| Nov 9, 2022 | K221855 | Universal CMF System Stryker Leibinger GmbH & Co KG, DE | JEY |
| May 27, 2022 | K220593 | Spine Guidance Software, Stryker Q Guidance System Stryker Leibinger GmbH & Co KG, DE | OLO |
| Aug 15, 2019 | K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit Stryker Leibinger GmbH & Co KG, DE | FWP |
| Nov 6, 2018 | K182425 | Universal Mesh - Sterile Stryker Leibinger GmbH & Co KG, DE | GWO |
| Oct 12, 2016 | K162341 | Stryker OrthoMap Precision Knee system Stryker Leibinger GmbH & Co KG, DE | OLO |
| Jul 18, 2014 | K141430 | VARIAX DISTAL RADIUS PLATING SYSTEM Stryker Leibinger GmbH & Co KG | HRS |
| Mar 24, 2014 | K133974 | VARIAX DISTAL RADIUS PLATING SYSTEM Stryker Leibinger GmbH | HRS |
| Jun 22, 2010 | K093108 | STRYKER BIPOLAR FORCEPS Stryker Leibinger GmbH & Co KG | GEI |
| Feb 19, 2009 | K083009 | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 Stryker Leibinger GmbH & Co KG, DE | OLO |
| Dec 16, 2005 | K052871 | STRYKER CUSTOM TI IMPLANT Stryker Leibinger | GXN |
| Apr 15, 2005 | K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT Stryker Leibinger | KKY |
| Sep 30, 2004 | K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM Stryker Leibinger | DZE |
| Mar 12, 2004 | K040022 | STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM Stryker Leibinger | HRS |
| Jun 2, 2003 | K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE Stryker Leibinger | HAW |
| Jan 13, 2003 | K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM Stryker Leibinger | IYE |
| Jan 8, 2002 | K013775 | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM Stryker Leibinger | HRS |
| Dec 3, 2001 | K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY Stryker Leibinger | HAW |
| Dec 8, 2000 | K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE Stryker Leibinger | JEY |
| May 3, 2000 | K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR Stryker Leibinger | IXI |
| May 3, 2000 | K000348 | COLORADO MICRODISSECTION NEEDLE Stryker Leibinger | GEI |
| Sep 22, 1999 | K991398 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT Stryker Leibinger | GXP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2026 | Stryker Leibinger GmbH & Co. KG Precision Pointer Electromagnetic (8000-050-001) Open, Classified |
HAW | K212194 |
| May 23, 2024 | Stryker Leibinger GmbH & Co. KG 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highl Open, Classified |
PGW | K221098 |
| May 8, 2024 | Stryker Leibinger GmbH & Co. KG Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton.
Catalog Number: 56-90614 Open, Classified |
GWO | K182425 |
| Mar 8, 2023 | Stryker Leibinger GmbH & Co. KG Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Open, Classified |
LZD | None listed |
| Dec 29, 2021 | Stryker Leibinger GmbH & Co. KG MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 Terminated |
FTM | K040364 |
| Apr 1, 2021 | Stryker Leibinger GmbH & Co. KG DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected ceme Terminated |
GXP | K143661 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2-
HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium. Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S
The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fi Terminated |
GWO | K120352 |
| Jun 22, 2018 | Stryker Leibinger GmbH & Co. KG QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S
The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid f Terminated |
GWO | K120352 |
| Feb 8, 2017 | Stryker Leibinger GmbH & Co. KG 9805
Orbital Volume Sizer Set with Tray (Non-sterile)
9951
Design M Malar Sizer Set (Silicone, Non-Sterile)
9952
Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile)
85000
Petite Nasal Dorsum S Terminated |
GCY | K833586 |
| Feb 8, 2017 | Stryker Leibinger GmbH & Co. KG QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile)
SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile)
Accessories to TLS Surgical Drainage System Terminated |
GCY | K833586 |
| Dec 30, 2008 | Stryker Leibinger USA Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911.
A mandibular plate and screw Terminated |
JEY | K014263 |
| Feb 27, 2007 | Stryker Leibinger USA Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407. Terminated |
LXH | None listed |