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Archer Patient Specific Instrumentation 1235-7153-001

by CATALYST ORTHOSCIENCE Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811596033064 UDI-DI Date3 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Archer Patient Specific Instrumentation
Generic Name
Custom-made orthopaedic/craniofacial surgical guide
Model / Ref / Catalog
1235-7153-001
Primary DI / UDI-DI
00811596033064
510(k) Number
FDA Product Code
QHE, PHX, KWS
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide
Device Class
Class II
Regulation Number
888.3660
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K243509)

Other devices from CATALYST ORTHOSCIENCE Inc

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (10)

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