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510(k) K841970

CAMELBACK HANDLE-K841969-LABELING by Stainless Mfg., Inc. — Product Code LXH

K841970 is an FDA 510(k) premarket notification submitted by Stainless Mfg., Inc. for the device "CAMELBACK HANDLE-K841969-LABELING". The FDA issued a decision of Substantially Equivalent on June 19, 1984. The device falls under product code LXH (Orthopedic Manual Surgical Instrument), a Class I device regulated under 21 CFR 888.4540. Stainless Mfg., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
May 14, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthopedic Manual Surgical Instrument
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type

Other clearances by Stainless Mfg., Inc.

  • K841980 — SIDE CUTTING SERRATED BLADE (August 15, 1984)
  • K841982 — MENISCOTOME 4MM & 5MM (June 19, 1984)
  • K841977 — 5MM DOUGLE EDGE RING CURETTE (June 19, 1984)
  • K841976 — HOOK KNIFE 4MM & 5MM (June 19, 1984)
  • K841979 — 4MM CUP CURRETTE (June 19, 1984)
  • K841972 — BANANA KNIFE - K841969-LABELING (June 19, 1984)
  • K841974 — RETROGRADE KNIFE 4MM & 5MM (June 19, 1984)
  • K841978 — LATERAL RELEASE KNIFE 5MM & 7MM (June 19, 1984)
  • K841981 — 4MM & 5MM FILE (June 19, 1984)
  • K841973 — BANANA KNIFE SERRATED (June 19, 1984)

Other clearances for product code LXH

  • K192873 — SX-One MicroKnife (December 20, 2019)
  • K140414 — IMBIBE NEEDLE (April 1, 2014)
  • K101609 — SELF RETAINING SOFT TISSUE RETRACTOR (December 9, 2010)
  • K001507 — MICROPERFORATION INSTRUMENT (June 14, 2000)
  • K952495 — ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM (January 22, 1996)
  • K943873 — ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY (April 26, 1995)
  • K944188 — SPINAL MARKER (April 13, 1995)
  • K941896 — STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR (November 7, 1994)
  • K941711 — HYPERFLEX FLEXIBLE GUIDEWIRES (August 26, 1994)
  • K941605 — STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSH (August 5, 1994)

FDA data resources