Brand Name | SOCON SCREW, 6MM X 40MM, TITANIUM ALLOY |
Type of Device | SPONDYLOLISTHESIS SPINAL FIXATION SCREW |
Baseline Brand Name | SOCON SCREW, 06MM X 40MM |
Baseline Generic Name | SPONDYLOLISTHESIS SPINAL FIXATION |
Baseline Catalogue Number | FG629T |
Other Baseline ID Number | 5068390 (LOT NUMBER) |
Baseline Device Family | SOCON IMPLANTS |
Baseline Device 510(K) Number | K970285 |
Baseline Device PMA Number | |
Baseline Preamendment? |
No
|
Transitional? |
No
|
510(K) Exempt? |
No
|
Shelf Life(Months) | NA |
Date First Marketed | 06/27/1997 |
Manufacturer (Section F) |
AESCULAP AG & CO. KG |
p.o. box 40 |
tuttlingen |
GERMANY
78501
|
|
Manufacturer (Section D) |
AESCULAP AG & CO. KG |
p.o. box 40 |
tuttlingen |
GERMANY
78501
|
|
Manufacturer Contact |
lia
jones
|
1000 gateway blvd |
so. san francisco
, CA 94080 |
(650)
624
-5073
|
|
Device Event Key | 250668 |
MDR Report Key | 258839 |
Event Key | 242615 |
Report Number | 2916714-2000-00001 |
Device Sequence Number | 1 |
Product Code | MNH |
Report Source |
Manufacturer
|
Source Type |
Company Representative
|
Reporter Occupation |
PHYSICIAN ASSISTANT
|
Type of Report
| Initial,Followup |
Report Date |
01/11/2000 |
1 Device Was Involved in the Event | |
1 Patient Was Involved in the Event | |
Date FDA Received | 01/12/2000 |
Is This An Adverse Event Report? |
Yes
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | FG629T |
Device LOT Number | 5068390 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 01/07/2000 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 01/06/2000 |
Was Device Evaluated By Manufacturer? |
Yes
|
Is The Device Single Use? |
Yes
|
Is the Device an Implant? |
Yes
|
Is this an Explanted Device? |
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 07/27/2000 Patient Sequence Number: 1 |
# | Treatment | Treatment Date |
1,FG601T: SOCON CLAMP, TITANIUM ALLOY., |
|
|
|