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510(k) K875249

SUTTER PHALANGEAL CAP by Sutter Biomedical, Inc. — Product Code KWD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Toe, Hemi-, Phalangeal
Device Class
Class II
Regulation Number
888.3730
Review Panel
OR
Submission Type

Other clearances by Sutter Biomedical, Inc.

  • K870200 — SUTTER FINGER JOINT PROSTHESIS (October 9, 1987)
  • K861983 — SUTTER LESSER METATARSAL CAP (September 8, 1986)
  • K850274 — SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT (April 25, 1985)
  • K830974 — SUTTER CPM 5000 (April 12, 1983)
  • K830649 — SUTTER CPM 2000 (March 17, 1983)
  • K823539 — SUTTER CPM (January 14, 1983)
  • K820813 — LESSER METATARSAL PHALANG. JOINT PROSTH (May 21, 1982)
  • K820083 — SUTTER CPM (January 28, 1982)
  • K812691 — SILICONE IMPLANTS (November 16, 1981)
  • K802342 — PROXIMAL INTERPHALANGEAL JOINT IMPLANT (October 14, 1981)

Other clearances for product code KWD

  • K240268 — Accu-Joint Hemi Implant (February 29, 2024)
  • K221220 — Montross Extremity Medical Hemi Implant System (April 19, 2023)
  • K222964 — BioPoly Lesser Toe Hemiarthroplasty Implant (November 22, 2022)
  • K201393 — restor3d MTP Implant (May 25, 2022)
  • K203634 — BioPoly Great Toe Hemiarthroplasty Implant (February 2, 2021)
  • K200951 — Accu-Joint Hemi Implant (December 8, 2020)
  • K190261 — BOSS Toe Fixation System (August 14, 2019)
  • K190543 — Cannulated Hemi Implant (May 31, 2019)
  • K161279 — Life Spine Metatarsal Hemi Implant (February 1, 2017)
  • K152454 — HemiCAP MTP Resurfacing Hemi-Arthroplasty System (April 11, 2016)