Plate, Bone
Regulation 872.4760
5510(k)s in 12 months (294 all time)
0recalls in 12 months (111 all time)
27recalls that name a 510(k)
Top companies in JEY
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Craniomaxillofacial Division | 0 | 81 |
| Synthes (Usa) | 42 | 2 |
| KLS Martin L.P. | 19 | 0 |
| Bioplate, Inc. | 16 | 2 |
| Walter Lorenz Surgical, Inc. | 15 | 3 |
| Biomet Microfixation | 8 | 7 |
| Stryker | 13 | 0 |
| Inion , Ltd. | 8 | 0 |
| Bionx Implants, Inc. | 7 | 0 |
| Medicon EG | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2023 | Materialise N.V. ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures.
Identificatio Completed |
JEY | K103136 |
| Dec 17, 2020 | Biomet, Inc. Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-12 - Product Usage: Fixation of Cranial bone Terminated |
JEY | K972322 |
| Jun 18, 2020 | Synthes, Inc. MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, Terminated |
JEY | K042365 |
| Jun 16, 2020 | Synthes Produktions GmbH MatrixMIDFACE Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repai Terminated |
JEY | K050608 |
| Feb 3, 2020 | Materialise N.V. TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013 Terminated |
JEY | K170272 |
| Feb 3, 2020 | Materialise N.V. TRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001 Terminated |
JEY | K170272 |
| May 7, 2018 | Zimmer Biomet, Inc. Lactosorb RapidFlap, bone plate, Model No. 915-0020
The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation. Terminated |
JEY | K003281 |
| Jun 7, 2016 | Synthes (USA) Products LLC 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in fractu Terminated |
JEY | K030069 K062789 |
| Jun 7, 2016 | Synthes (USA) Products LLC 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in fractu Terminated |
JEY | K030069 K062789 |
| Jun 7, 2016 | Synthes (USA) Products LLC 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in frac Terminated |
JEY | K030069 K062789 |
| Jul 28, 2015 | Synthes (USA) Products LLC Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intende Terminated |
JEY | K083388 |
| Mar 12, 2013 | Synthes USA HQ, Inc. Synthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones. Terminated |
JEY | K010499 |
| Mar 23, 2012 | Biomet Microfixation, LLC Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM Terminated |
JEY | K953385 |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 35mm Flex Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPOR Terminated |
JEY | K002083 |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRAD Terminated |
JEY | K002083 |
| Jan 11, 2012 | Walter Lorenz Surgical, Inc. Product is 40mm Flexible Tube. ***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN."
W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 T Terminated |
JEY | K002083 |
| Nov 1, 2011 | Bioplate Inc Bioplate Titanium Fixation System, Sterile Kit.
The sterile plate and screw kit configurations for use with the Bioplate Titanium Fixation System are intended for use on non-load bearing fixation, in Terminated |
JEY | K082757 |
| May 27, 2011 | Biomet Microfixation, Inc. ***BIOMET MICROFIXATION BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA www.biometmicrofixation.com***6 HOLE REGULAR DOUBLE Y PLATE***"1.5MM SYSTEM PLATE DOUBLE Y-SHAPE, REGULAR 0 Terminated |
JEY | K953385 |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
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