510(k) K974025 ยท GFF Bur, Surgical, General & Plastic Surgery
ANSPACH SHIELDED ATTACHMENT
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jul 6, 1998 |
| Received | Oct 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. 19cm Attachment, Black Max
Product Usage:
Pneumatic system Terminated |
GFF | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 19CM ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 11.25CM ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. LARGE CRANIOTOME, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. STANDARD CRANIOTOME, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. KEYLESS DRIVER, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 26.65CM ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 12.6CM TAPERED ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 5.9CM ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. PEDIATRIC CRANIOTOME, BM
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 8.2CM ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Large Craniotome
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Jan 27, 2014 | The Anspach Effort, Inc. AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only
Single use Sterile bone cutting burs. Terminated |
HBC | None listed |
| Jan 27, 2014 | The Anspach Effort, Inc. Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only
Single use Sterile bone cutting burs. Terminated |
GFF | None listed |
| Jul 25, 2012 | The Anspach Effort, Inc. .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only
Product Usage:
Cutting and shaping bone including bones of the spin Terminated |
HTW | None listed |
| Sep 14, 2011 | The Anspach Effort, Inc. Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Driv Terminated |
HBC | None listed |
| Sep 14, 2011 | The Anspach Effort, Inc. Cutting Burr labeled in part:"***TURQ-434-4 QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with B-TURQUOISE Attachment.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riversi Terminated |
HBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.