MNI · Class II · 21 CFR 888.3070

FDA Product Code MNI: Orthosis, Spinal Pedicle Fixation

Leading manufacturers include Synthes (Usa), Howmedica Osteonics Corp. and Depuy, Inc..

303
Total
303
Cleared
95d
Avg days
1998
Since

FDA 510(k) Cleared Orthosis, Spinal Pedicle Fixation Devices (Product Code MNI)

303 devices
1–24 of 303
Cleared Feb 20, 2004
STRYKER SPINE OASYS SYSTEM
K032394
Howmedica Osteonics Corp.
Orthopedic · 200d
Cleared Mar 24, 2003
SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS
K022949
Synthes (Usa)
Orthopedic · 200d
Cleared Mar 06, 2003
MODIFICATION TO SYNTHES CERVIFIX SYSTEM
K030377
Synthes (Usa)
Orthopedic · 29d
Cleared Apr 15, 2002
SYNTHES DUAL-OPENING USS
K020517
Synthes (Usa)
Orthopedic · 55d
Cleared Jun 04, 2001
MODIFIED USS FRACTURE SYSTEM
K010658
Synthes (Usa)
Orthopedic · 90d
Cleared Oct 17, 2000
SMALL STATURE USS
K994121
Synthes (Usa)
Orthopedic · 316d
Cleared May 11, 2000
MULTI-AXIAL CROSS (MAC) CONNECTOR
K000965
Howmedica Osteonics Corp.
Orthopedic · 45d
Cleared Dec 20, 1999
OPUS SPINAL SYSTEM
K993402
Howmedica Osteonics Corp.
Orthopedic · 73d
Cleared Jan 28, 1999
OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS
K990059
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared Dec 30, 1998
DEPUY ACROMED MOSS SPINAL SYSTEM
K984378
Depuy, Inc.
Orthopedic · 23d

About Product Code MNI - Regulatory Context