FDA.report

DSS™ Distraction instrument

Primary DI
04260148893407
Brand
DSS™ Distraction instrument
Company
Paradigm Spine, LLC
Model
DAT70301
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04260148893407PrimaryGS10

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
787874960
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04260148898259CoFix Implant 12 mmRQI00012RQI000122020-03-19
04260148898266CoFix Implant 14 mmRQI00014RQI000142020-03-19
04260148898273CoFix Implant 16 mmRQI00016RQI000162020-03-19
04260148897931CoFix Sterilization TrayRAC100002020-03-04
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04260148897856coflex MalletUAT201202018-08-02
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04260148897740coflex trial with guide and x-ray marker, 8mmUXT100082018-06-28
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04260148897771coflex trial with guide and x-ray marker, 14mmUXT100142018-06-28
04260148897788coflex trial with guide and x-ray marker, 16mmUXT100162018-06-28

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