DEVICE: MONOPOLY (04047844006054)

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Device Identifier (DI) Information

MONOPOLY
MONOPOLY
MP0220-4550
SIGNUS Medizintechnik GmbH
04047844006054
GS1
1
Indications for Use: The MONOPOLY Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral spine (T1-S1), specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the MONOPOLY Pedicle Screw System is intended for one or more of the following indications: - degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) - degenerative spondylolisthesis with objective evidence of neurologic impairment - fracture - dislocation - spinal tumor, and/or - failed previous fusion (pseudarthrosis) When used as a non-cervical and non-pedicle screw fixation system, the MONOPOLY Pedicle Screw System is intended for the following indications: - degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the discconfirmed by patient history and radiographic studies) - spinal stenosis - spondylolistheses - trauma (fracture, dislocation) - pseudarthrosis - tumor resection and/or - failed previous Fusion
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Bone-screw internal spinal fixation system, sterile An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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FDA Product Code

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Product Code Product Code Name
NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
KWP Appliance, Fixation, Spinal Interlaminal
MNH Orthosis, Spondylolisthesis Spinal Fixation
MNI Orthosis, Spinal Pedicle Fixation
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Ø4.5x50mm
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Device Status

In Commercial Distribution
August 31, 2014

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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+49602391660
info@signus.com
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