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Spatial Frame 71070154

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

19 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 Number03596010432827 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

19 recalls · FDA

  • 18 recalls, same reason

    • Terminated Z-1754-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1750-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1755-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1751-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1758-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1749-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1762-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1761-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1757-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1752-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1748-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1753-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1759-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1763-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1760-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1747-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1765-2012 FDA Not yet classified initiated 13 Apr 2012
    • Terminated Z-1756-2012 FDA Not yet classified initiated 13 Apr 2012

    Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.

    • Terminated Z-2027-2009 FDA Unclassified (pre-2012) initiated 23 Jan 2009

    Hinge failure: The product is cracking or breaking during use.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Spatial Frame
Generic Name
External orthopaedic fixation system, single-use
Model / Ref / Catalog
71070154
Primary DI / UDI-DI
03596010432827
510(k) Number
FDA Product Code
JDW
GMDN Term
External orthopaedic fixation system, single-use
Device Class
Class II
Regulation Number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Category: External orthopaedic fixation system, single-use

Cleared under the same submission (K994143)

Show all (12)

Other devices from Smith & Nephew, Inc.

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Properties

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

Other properties (10)

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