510(k) K133604 ยท HBC Motor, Drill, Electric
ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Jan 10, 2014 |
| Received | Nov 25, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2023 | The Anspach Effort, Inc. 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems.
Ref: CRANI-A
Intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax,
microMax, and eMax Systems
Ref: CRANI-A-01
intended for cutting and shaping bone including the spine and cranium by trained medica Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. Adult Craniotome
Ref: CRANI-A-G1
Intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems
Ref: CRANI-A-R
intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. 7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax
Systems.
Ref: CRANI-L
Intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. Adult Craniotome, Large
Ref: CRANI-L-G1
Intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. 7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems
Ref: CRANI-L-R
Intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. 6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems
Ref: CRANI-P
Intended for cutting and shaping bone including the spine and cranium Open, Classified |
HBC | None listed |
| Jan 7, 2023 | The Anspach Effort, Inc. Pediatric Craniotome
Ref:CRANI-P-G1 Open, Classified |
HBC | None listed |
| Jun 15, 2016 | The Anspach Effort, Inc. Anspach G1 High Speed Electric Handpiece Air Cooled (eG1A)
Use for cutting and shaping bone including bones of the cranium and spine. Terminated |
HBC | None listed |
| Feb 2, 2015 | The Anspach Effort, Inc. 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1 Terminated |
HBC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.