510(k) K955084 ยท HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
ASPACH 65,000 (MODIFICATION)
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 17, 1996 |
| Received | Oct 19, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955084
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. BLACKMAX-NEURO LOW PRESSURE
Product Usage:
Pneumatic system Terminated |
HSZ | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. GREEN ROTATING CRANIOTOME, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. ADJUSTABLE DRILL GUIDE, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 16CM MIN INVASIVE ATTACH, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 22CM MICRO REVISION ATTACH, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 16.5CM MICRO REVISION ATTACH, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 9.4CM MICRO REVISION ATTACH, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. CONTRA ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 90 DEG RIGHT ANGLE ATTACH, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 11CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 10.5CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 14CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 13.5CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 8CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 7.5CM ANGLE ATTACHMENT, BLACK MAX Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. B-SAGITTAL ASSEMBLY
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 6.1CM ATTACHMENT, BLACK MAX
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 45 degree Contra Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. 90 degree Contra Angle Attachment
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Jul 3, 2014 | The Anspach Effort, Inc. Anspach Pneumatic and Electric Motor Systems.
Intended for cutting and shaping bone, including the spine and cranium. Terminated |
HSZ | None listed |
| Jan 9, 2014 | The Anspach Effort, Inc. ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc.
Intended for cutting and shaping bone. Terminated |
HSZ | None listed |
| Nov 13, 2013 | The Anspach Effort, Inc. Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, Terminated |
HSZ | None listed |
| Jul 11, 2007 | The Anspach Effort, Inc. Anspach Single Use, Sterile Bone Cutting Burrs Terminated |
HBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.