510(k) K953385 ยท JEY Plate, Bone
LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEM
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Sep 28, 1995 |
| Received | Jul 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K953385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| Jan 23, 2012 | Biomet Microfixation, Inc. Package of cross-drive bone screws labeled in part: "***REF #95-1504***"1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, 5/ PK***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE Terminated |
NDJ | None listed |
| Jan 23, 2012 | Biomet Microfixation, Inc. Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE Terminated |
NDJ | None listed |
| Jul 22, 2011 | Biomet Microfixation, Inc. "***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA* Terminated |
HWC | None listed |
| 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 | None listed |
| Aug 11, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION "1.5MM" SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW, QTY 1, 1.5 X 4MM TITANIUM. REF 91-1504 1 COUNT and REF 95-1504 - 5 PACK.
BIOMET MICROFIXATION 1520 TRADEPORT DRIVE, JACKSONVIL Terminated |
DZL | None listed |
| Jun 30, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***.
Bone screws used along with implantable bone pl Terminated |
JEY | None listed |
| Mar 17, 2010 | Biomet Microfixation, Inc. BIOMET MICROFIXATION, "1.5MM" SYSTEM BONE SCREW LP, SELF DRILL, X-DRIVE, SGL.LEAD AUGER POINT, 1.5 X 3.5MM, TITANIUM, NON STERILE PRODUCT. Model 01-7293 and 99-7293-01. BIOMET MICROFIXATION, 1520 TR Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.