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510(k) K930573

SYNVASIVE CERAMIC SUTTING BLOCK by Synvasive Technology, Inc. — Product Code LXI

K930573 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "SYNVASIVE CERAMIC SUTTING BLOCK". The FDA issued a decision of Substantially Equivalent on April 7, 1994. The device falls under product code LXI (Guide, Drill, Ligament), a Class I device regulated under 21 CFR 878.4820. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1994
Date Received
February 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Drill, Ligament
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type

Other clearances by Synvasive Technology, Inc.

  • K093046 — ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES (March 22, 2011)
  • K070108 — ELIBRA DYNAMIC KNEE BALANCER (April 4, 2007)
  • K972508 — SURGICAL BURS AND SURGICAL DRILL BITS (August 26, 1997)
  • K961522 — KIRSCHNER WIRE (K-WIRE) AND STEINMANN PIN (September 23, 1996)
  • K950009 — POWERGRIP(TM) COMPRESSION FIXATION DEVICE (August 18, 1995)
  • K934336 — SPINALPLANE (March 10, 1995)
  • K933933 — CEBOPLANE (April 15, 1994)
  • K932869 — ARTHROPLANE (March 25, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)

Other clearances for product code LXI

  • K910712 — VILLAN (VIDEO LIFT LINK ANALYSIS) (May 21, 1991)
  • K892655 — ACL DRILL GUIDE SYSTEM (September 28, 1989)
  • K890445 — PERSONAL ALERT ASSIST DEVICE (May 19, 1989)
  • K882407 — BOW & ARROW DRILL GUIDE (September 6, 1988)
  • K881378 — PFIZER HOSPITAL PRODUCTS GROUP ACL DRILL GUIDE (June 17, 1988)
  • K880739 — DYONICS DRILL GUIDE/ISOMETER SYSTEM (March 21, 1988)
  • K854254 — TENSION-ISOMETER (November 15, 1985)

FDA data resources