Atlas FDA

ANSPACH DISSECTION TOOLS

FDA 510(k) clearance K113476 · decided 2011-12-16

Clearance details

K-number
K113476
Device name
ANSPACH DISSECTION TOOLS
Applicant
The Anspach Effort, Inc.
Decision
Substantially Equivalent
Date received
2011-11-22
Decision date
2011-12-16
Days to decision
24 days
Clearance type
Special
Product code
HBE
Device class
2
Regulation number
882.4310
Medical specialty
Neurology
Advisory committee
Neurology
Location
Palm Beach Gardens, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone inc recall (Z-2280-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone incl recall (Z-2281-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone recall (Z-2282-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone includ recall (Z-2283-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium. recall (Z-2284-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone includ recall (Z-2285-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine an recall (Z-2286-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine an recall (Z-2287-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone inclu recall (Z-2288-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine recall (Z-2289-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium. recall (Z-2290-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone inclu recall (Z-2291-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 3MM Course Diamond Ball, 2 MM Shaft Exposure; REF M-3DC-2-G1 Cutting shaping bon recall (Z-2292-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 3MM Fluted Ball, 2 MM Shaft Exposure; REF M-3SB-2-G1. Cutting shaping bone inclu recall (Z-2293-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 4MM x 11 MM Fluted Barrel, 14 Flutes; REF M-4BA-A-G1. Cutting shaping bone inclu recall (Z-2294-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 5MM Fluted Ball, 2 mm Shaft Exposure; REF M-5B-2-G1. Cutting shaping bone includ recall (Z-2295-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 5MM x 11.3MM Fluted Barrel; REF M-5BA-A-G1 Cutting shaping bone including spine recall (Z-2296-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 6MM x 11.3MM Fluted Barrel; REF M-6BA-A-G1 Cutting shaping bone including spine recall (Z-2297-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 6MM Coarse Diamond Ball, 2 mm Shaft Exposure; REF M-6DC-2-G1 Cutting shaping bon recall (Z-2298-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 7MM Fluted Acorn; REF M-7AC-G1 Cutting shaping bone including spine and cranium. recall (Z-2299-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 7MM Extra Coarse Diamond Ball; REF M-7DX-G1 Cutting shaping bone including spine recall (Z-2300-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 8MM x 12.5MM Fluted Barrel; REF M-8BA-G1 Cutting shaping bone including spine an recall (Z-2301-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 4MM Fluted Ball, Extends 27MM; REF M-4B-27-G1. Cutting shaping bone including sp recall (Z-2302-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 5MM Fluted Ball, Extends 27MM; REF M-5B-27-G1. Cutting shaping bone including sp recall (Z-2303-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH -1.5MM x 7.5MM Cylindrical Carbide Drum, Extends 25MM; REF S-15DRMC-L-G1. Cutting recall (Z-2304-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH -3MM Coarse Diamond Ball,72MM Shaft Exposure; REF S-3SDC-22-G1. Cutting shaping bo recall (Z-2305-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone inclu recall (Z-2306-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-4DC-22-G1 Cutting shaping bon recall (Z-2307-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 4MM Diamond Ball, Extends 27MM; REF S-4D-L-G1 all lot numbers Cutting shaping bo recall (Z-2308-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure; REF S-5B-2-G1 Cutting shaping bone includin recall (Z-2309-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure; REF S-5D-2-G1 Cutting shaping bone includi recall (Z-2310-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure; REF S-5DC-22-G1 Cutting shaping bo recall (Z-2311-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM; REF S-8N-L-G1 Cutting shaping bone includ recall (Z-2312-2015)The Anspach Effort, Inc.2015-07-29
ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive; REF S-8NS-M-G1 Cutting sh recall (Z-2313-2015)The Anspach Effort, Inc.2015-07-29
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. recall (Z-1377-2013)The Anspach Effort, Inc.2013-05-24