510(k) K802598 ยท HTT Burr, Orthopedic
CARBIDE CUTTING INSTRUMENT/INTRAARTICU
| Applicant | The Anspach Effort, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 19, 1980 |
| Received | Oct 21, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF QD11-6B***6 mm Fluted Ball. Use with QD11 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside D Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF QD8-5B***5 mm Fluted Ball. Use with QD8 Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Dri Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF BLU-5***5 mm Fluted Ball. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF BLU-39***5 mm Fluted Acorn. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riversid Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF BLU-LS9-5E***4.7 mm x 20 mm Fluted Drum, Side Cut Only. Use with B-BLUE-S Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspa Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF GRE-1***1.85 mm x 16 mm Fluted Router. Use with B-GREEN Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. 45 Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF LHD-6B-M***6 mm Fluted Ball. Use with LONG-HD Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riversid Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. '***REF SIL-3-10***1.93 mm Suture Pass Drill/ 1.17 eye. Use with B-SILVER Attachment.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF TURQ-L5***5 mm Fluted Ball. Use with B-TURQ-L Attachment. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Rivers Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF L-CRN***2.5 mm x 25.4 mm Fluted Router. Use with CRANI-L Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the
USA***Manufacturer: The Anspach Effort, Inc Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF A-CRN***1.85 mm x 16 mm Fluted Router. Use with CRANI-A Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only ***Made in the USA***Manufacturer: The Anspach Effort, Inc. Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF S-35DC***3.5 mm Coarse Diamond Ball, Extended Length. Use with SHORT Attachments.***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Eff Terminated |
HTT | None listed |
| Oct 21, 2011 | The Anspach Effort, Inc. "***REF S-6AC***6 mm Fluted Acorn. Use with SHORT Attachments. ***ANSPACH***Sterile, Sterilized using Irradiation***Rx Only***Made in the USA***Manufacturer: The Anspach Effort, Inc. 4500 Riverside D Terminated |
HTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.