510(k) K113476 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
ANSPACH DISSECTION TOOLS
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Nov 22, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113476
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 7mm FBALL L; For cutting and shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 3mm CRS DBALL, 2mm SHAFT EXP, M; For cutting and shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 3mm FLUTED BALL; For cutting and shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Aug 26, 2016 | The Anspach Effort, Inc. G1 Dissection Tool - 6MM CRS DBALL, 2mm Shaft EXP, M; For cutting and shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM ,
REF L-5DRC-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM
REF L-6DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Acorn, 7MM
REF L-7AC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM
REF L-7DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Barrel; 8MM x 12.5MM
REF L-8BA-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Barrel; 8MM x 12.5MM
REF L-8BA-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only;
REF L-8DRC-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Extra Coarse Diamond Ball; 8MM
REF L-8DX-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Ball; 9MM
REF L-9B-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM
REF L-9DRC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM x 11.3MM Fluted Barrel;
REF M-5BA-A-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 6MM x 11.3MM Fluted Barrel;
REF M-6BA-A-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 7MM Fluted Acorn;
REF M-7AC-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 7MM Extra Coarse Diamond Ball;
REF M-7DX-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 8MM x 12.5MM Fluted Barrel;
REF M-8BA-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 4MM Fluted Ball, Extends 27MM;
REF M-4B-27-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Fluted Ball, Extends 27MM;
REF M-5B-27-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -4MM Carbide Fluted Ball, Extends 27MM;
REF S-4BL-C-G1.
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure;
REF S-5D-2-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM;
REF S-8N-L-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| Jul 29, 2015 | The Anspach Effort, Inc. ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1
Cutting shaping bone including spine and cranium. Terminated |
HBE | None listed |
| May 24, 2013 | The Anspach Effort, Inc. ***REF S-3D*** 3mm Diamond Ball.
Used for cutting and shaping bone. Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.