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Na CSR60

by Synthes

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00845384001782 UDI-DI Date5 Feb 2018ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1993-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K960630
    • Terminated Z-1992-2017 FDA Class II initiated 6 Oct 2016 on shared 510(k) K960630

    Supplied Directions for Use (DFU) did not contain a recommended service interval.

  • 2 recalls, same reason

    • Terminated Z-1901-2014 FDA Class II initiated 28 Nov 2012
    • Terminated Z-1900-2014 FDA Class II initiated 28 Nov 2012

    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Burring power tool attachment
Model / Ref / Catalog
CSR60
Primary DI / UDI-DI
00845384001782
510(k) Number
FDA Product Code
HBB
GMDN Term
Burring power tool attachment
Device Class
Class II
Regulation Number
882.4370
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Synthes

See all devices from Synthes →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No