Atlas FDA

ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM

FDA 510(k) clearance K042783 · decided 2004-12-17

Clearance details

K-number
K042783
Device name
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
Applicant
The Anspach Effort, Inc.
Decision
Substantially Equivalent
Date received
2004-10-06
Decision date
2004-12-17
Days to decision
72 days
Clearance type
Traditional
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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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Surgify Halo (54.085.SHD.U1); Surgify Halo (54.140.SHD. U1); Surgify Halo (54.070.NVG.U1); Surgify Halo (54.125.NVG.U1); Surgify Halo (54.000.SEE.U1); Surgify Halo (40.070.NVG.U1); Surgify Halo (40.125.NVG.U1); Surgify Halo (40.000.SEE.U1); Surgify Halo (30.070.NVG.U2); Surgify Halo (30.125.NVG.U2); Surgify Halo (30.000.SEE.U2) (K253627)Surgify Medical OY2026-03-26
Hubly Drill (H100) (K250815)Hubly, Inc.2025-11-06
GREEN (K252060)Phasor Health, LLC2025-10-31
UniBur (K252662)Nakanishi, Inc.2025-09-19
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1) (K251433)Surgify Medical OY2025-06-04
Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1) (K250380)Surgify Medical OY2025-03-13
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R (K250374)Stryker Instruments2025-03-11
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2.1 x 255mm Drill, 22mm Stop (K223199)Biomet Microfixation2022-11-15
2.1 x 255mm Drill, 22mm Stop (K213072)Biomet Micofixation2022-08-23
Twist Drills (K213208)Biomet Microfixation2021-12-23

Recalls involving this device

RecordFirmDate
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. recall (Z-0749-2014)The Anspach Effort, Inc.2014-01-15
MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use recall (Z-0750-2014)The Anspach Effort, Inc.2014-01-15
MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0751-2014)The Anspach Effort, Inc.2014-01-15
MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0752-2014)The Anspach Effort, Inc.2014-01-15
MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0753-2014)The Anspach Effort, Inc.2014-01-15
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in recall (Z-0754-2014)The Anspach Effort, Inc.2014-01-15
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use i recall (Z-0755-2014)The Anspach Effort, Inc.2014-01-15
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cu recall (Z-0756-2014)The Anspach Effort, Inc.2014-01-15
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in c recall (Z-0757-2014)The Anspach Effort, Inc.2014-01-15
MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cu recall (Z-0758-2014)The Anspach Effort, Inc.2014-01-15
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in c recall (Z-0759-2014)The Anspach Effort, Inc.2014-01-15
MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0760-2014)The Anspach Effort, Inc.2014-01-15
MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0761-2014)The Anspach Effort, Inc.2014-01-15
MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0762-2014)The Anspach Effort, Inc.2014-01-15
MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0763-2014)The Anspach Effort, Inc.2014-01-15
MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in recall (Z-0764-2014)The Anspach Effort, Inc.2014-01-15
MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use i recall (Z-0765-2014)The Anspach Effort, Inc.2014-01-15
MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cu recall (Z-0766-2014)The Anspach Effort, Inc.2014-01-15
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in c recall (Z-0767-2014)The Anspach Effort, Inc.2014-01-15
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cu recall (Z-0768-2014)The Anspach Effort, Inc.2014-01-15
MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in c recall (Z-0769-2014)The Anspach Effort, Inc.2014-01-15
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, prim recall (Z-0715-2014)The Anspach Effort, Inc.2014-01-10
Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters recall (Z-0708-2014)The Anspach Effort, Inc.2014-01-09
"***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (M recall (Z-2903-2011)The Anspach Effort, Inc.2011-08-01