510(k) K042783 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
| Applicant | The Anspach Effort, Inc., Palm Beach Gardens FL, US |
| Decision | Substantially Equivalent, Dec 17, 2004 |
| Received | Oct 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042783
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 10CM Curved
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 10CM Straight
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 15CM Curved
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 15CM Straight
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Bearing Sleeve, 15CM Straight Taper
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Minimal Access Attachment
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Oct 6, 2016 | The Anspach Effort, Inc. Minimal Access Straight Driver
Product Usage:
Pneumatic system Terminated |
BWN | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA
Intended for use in cutting and shaping delicate bone material, primarily in otologic proced Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 15, 2014 | The Anspach Effort, Inc. MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall.
Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Terminated |
HBE | None listed |
| Jan 10, 2014 | The Anspach Effort, Inc. Anspach MCA Cutting Burr, DFU Rx Only
Designed for cutting and shaping delicate bone, primarily in otology procedures Terminated |
HBE | None listed |
| Jan 9, 2014 | The Anspach Effort, Inc. Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments)
MCA - MICRO CURVED ATTACHMENT,
MCA5-05SD - 0.5MM DIAMOND BALL, 5.6CM,
MCA5-06SD - 0.6MM DIA Terminated |
HBE | None listed |
| Aug 1, 2011 | The Anspach Effort, Inc. "***REF MCA5-15SB QTY: 1***1.5 mm Fluted Ball, 5.6 cm. Use with Micro Curved Attachment (MCA).***Sterilized using Irradiation***RX Only***ANSPACH Manufacture The Anspach Effort, Inc. 4500 Riverside D Terminated |
HBE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.