DEVICE: InSpan® (00190361000624)

Device Identifier (DI) Information

InSpan®
IM61000-16
In Commercial Distribution

SPINEFRONTIER, INC.
00190361000624
GS1

1
002003243 *Terms of Use
ISP Plate, 8x39mm
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Interspinous spinal fixation implant A non-sterile implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device intended to be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102020 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Width: 8 Millimeter
Length: 39 Millimeter
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Device Record Status

6b4d72f8-d691-4c69-9d6d-5460b4cfeb9f
July 06, 2018
3
April 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(866)914-7717
customerservice@spinefrontier.com
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