DEVICE: SeaSpine Spacer System - Ventura™ (10889910058991)

Device Identifier (DI) Information

SeaSpine Spacer System - Ventura™
33-2815
Not in Commercial Distribution
33-2815
SEASPINE ORTHOPEDICS CORPORATION
10889910058991
GS1
September 02, 2016
1
079840876 *Terms of Use
Ventura Implant, 9mm x 28mm x 15mm
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57806 Vertebral body prosthesis, non-sterile
A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
MQP SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K052170 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
Device Size Text, specify: 9mm x 28mm x 15mm
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Device Record Status

3f8c5e59-e0f3-4ef7-9bc6-1b88bedffca6
July 06, 2018
3
November 09, 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)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(866)942-8698
custsvcspine@seaspine.com
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