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Stayfuse

by Pioneer Surgical Technology

510(k) K990804

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK990804 Date29 Apr 1999ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0561-04 FDA Unclassified (pre-2012) initiated 20 Jan 2004

    Product labeled as size 3.8x6 mm implant may actually be size 4.3x6 mm implant.

    • Terminated Z-0948-03 FDA Unclassified (pre-2012) initiated 28 May 2003

    Label may bear an incorrect part number [2227-02-02] and size [03.8MM].

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HWC
Device class
Class II
Regulation
21 CFR Part 888.3040
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

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