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510(k) K801969

ASNIS GUIDED SCREW SYSTEMS by Howmedica Corp. — Product Code HNC

K801969 is an FDA 510(k) premarket notification submitted by Howmedica Corp. for the device "ASNIS GUIDED SCREW SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 27, 1980. The device falls under product code HNC (Specula, Ophthalmic), a Class I device regulated under 21 CFR 886.4350. Howmedica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1980
Date Received
August 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Specula, Ophthalmic
Device Class
Class I
Regulation Number
886.4350
Review Panel
OP
Submission Type

Other clearances by Howmedica Corp.

  • K984251 — XIA SPINE SYSTEM (February 24, 1999)
  • K984202 — HOWMEDICA HUMERAL INTERCALARY SYSTEM (February 5, 1999)
  • K984305 — ZETA MULTIZONE LOCKING NAIL SYSTEM (February 1, 1999)
  • K983885 — BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES (January 29, 1999)
  • K983528 — MICRO DYNAMIC MESH (December 23, 1998)
  • K983404 — TYPE 3 FEMORAL COMPONENTS (December 22, 1998)
  • K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION (December 16, 1998)
  • K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION (December 11, 1998)
  • K980632 — DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION (December 11, 1998)

Other clearances for product code HNC

  • K022836 — STEPHENS DISPOSABLE SPECULUM (November 1, 2002)
  • K981235 — OCULOSTAT (July 15, 1998)
  • K964289 — EYE FIXATION SPECULUM (December 17, 1996)
  • K863989 — THORNTON TITANIUM SPECULUM (MODIFIED BARRAQUER) (October 31, 1986)
  • K863664 — OPHTHALMIC SURGICAL SPECULUM (September 25, 1986)
  • K843196 — VISITEC EYE SPECULUM (October 5, 1984)
  • K830430 — EYELID SPECULUM (June 10, 1983)
  • K760849 — FELDSTEIN BLEPHAROSTOMY CLIP SQUARE (November 2, 1976)
  • K760848 — FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (November 2, 1976)
  • K760847 — FELDSTEIN BLEPHAROPLASTY CLIP SHARP P (November 2, 1976)

FDA data resources