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510(k) K894184

BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM by Biedermann Motech GmbH — Product Code JDN

K894184 is an FDA 510(k) premarket notification submitted by Biedermann Motech GmbH for the device "BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM". The FDA issued a decision of SN on April 25, 1990. The device falls under product code JDN (Implant, Fixation Device, Spinal), a Class II device regulated under 21 CFR 888.3060. Biedermann Motech GmbH has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SN ()
Decision Date
April 25, 1990
Date Received
June 16, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Fixation Device, Spinal
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Biedermann Motech GmbH

  • K900138 — MOTECH TITANIUM SURGICAL MESH (March 20, 1990)

Other clearances for product code JDN

  • K954856 — CANNULATED FEMORAL NAIL (March 8, 1996)
  • K897141 — SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO (June 21, 1990)
  • K872715 — UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY (December 7, 1987)
  • K873977 — NEW C-D SYSTEM FOR SPINAL SURGERY (December 7, 1987)
  • K760649 — TOTAL SPINAL CORRECTION (October 5, 1976)

FDA data resources