Home / 510(k) Clearances / K070108

510(k) K070108

ELIBRA DYNAMIC KNEE BALANCER by Synvasive Technology, Inc. — Product Code ONN

K070108 is an FDA 510(k) premarket notification submitted by Synvasive Technology, Inc. for the device "ELIBRA DYNAMIC KNEE BALANCER". The FDA issued a decision of Substantially Equivalent on April 4, 2007. The device falls under product code ONN (Intraoperative Orthopedic Joint Assessment Aid), a Class II device regulated under 21 CFR 882.4560. Synvasive Technology, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2007
Date Received
January 11, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intraoperative Orthopedic Joint Assessment Aid
Device Class
Class II
Regulation Number
882.4560
Review Panel
OR
Submission Type

Measurement and interpretation of orthopedic joint information.

Other clearances by Synvasive Technology, Inc.

  • K093046 — ELIBRA UNI SOFT-TISSUE FORCE SENSOR, MODEL 61-XXXX(5 MODELS, DIFFERENT SIZES (March 22, 2011)
  • 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)
  • K930573 — SYNVASIVE CERAMIC SUTTING BLOCK (April 7, 1994)
  • K932869 — ARTHROPLANE (March 25, 1994)
  • K931737 — HEDLEYL INTRAMEDULLARY PREPARATION BRUSH (January 7, 1994)

Other clearances for product code ONN

  • K262253 — Lantern Knee Navigation Unit (406000-03);Lantern Hip Navigation Unit (502000-03) (July 31, 2026)
  • K253507 — Packaged Assembly, Reusable Navigation Unit; Lantern ASC, Smart Pack kit, Knee (June 2, 2026)
  • K252524 — Quadsense (Quadsense and Quadsense Pro) (September 9, 2025)
  • K241298 — QUADSENSE (October 4, 2024)
  • K242616 — Lantern® Hip (October 3, 2024)
  • K220830 — TrueBalance™ Surgical System (September 15, 2022)
  • K200587 — VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size (August 25, 2020)
  • K200665 — VERASENSE for Stryker Triathlon (April 12, 2020)
  • K193580 — VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet (April 1, 2020)
  • K180459 — VERASENSE for Zimmer Biomet Persona (June 7, 2018)

FDA data resources