Chrysalis Intelligence · Sponsors · The Anspach Effort, Inc.

The Anspach Effort, Inc.

Palm Beach Gardens, FL, US · 1 510(k) clearances · 9 recalls

Total clearances
1
2022-05-19 → 2022-05-19
Last 12 months
0
Product codes
1
Most recent
2022-05-19
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HBC 1 2022-05-19
Safety

Recalls (9)

Class I (serious)
0
Risk of injury / death
Total recalls
9
Currently ongoing
9
Most recent
2022-12-07
DateSeverityStatusRecall # ProductCodeReason
2022-12-07 Class II Ongoing Z-0924-2023 Pediatric Craniotome Ref:CRANI-P-G1 Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0923-2023 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutt… Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0922-2023 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended f… Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0921-2023 Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0920-2023 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting… Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0919-2023 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended f… Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0918-2023 Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0917-2023 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 … Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
2022-12-07 Class II Ongoing Z-0916-2023 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended fo… Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-oper…
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2022-05-19 K220485 Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) HBC