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510(k) K982931

THREADED FIXATION PIN by Sgarlato Laboratories, Inc. — Product Code JDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1998
Date Received
August 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pin, Fixation, Threaded
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K926262 — FIRST MPJ CONTINUOUS PASSIVE MOTION DEVICE (January 26, 1994)
  • K926237 — O'BRIEN GONIOMETER (August 2, 1993)
  • K922292 — LUNDEEN SUBTALAR PEG IMPLANT (October 23, 1992)
  • K905795 — SGARLATO FLEXIBLE HINGE TOE IMPLANT (May 29, 1991)
  • K884739 — SGARLATO LESSER TOE IMPLANT (May 18, 1989)

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