SeaSpine Spacer System - Hollywood NanoMetalene 34-9114

GUDID 10889981064648

Hollywood VI NM Implant, 11mm x 30mm x 14mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

Primary Device ID	10889981064648
NIH Device Record Key	96f9ce8c-bbf8-499f-9111-c64c57b00fd5
Commercial Distribution Status	In Commercial Distribution
Brand Name	SeaSpine Spacer System - Hollywood NanoMetalene
Version Model Number	34-9114
Catalog Number	34-9114
Company DUNS	079840876
Company Name	SEASPINE ORTHOPEDICS CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(760)727-8399
Email	custsvcspine@seaspine.com
Phone	+1(760)727-8399
Email	custsvcspine@seaspine.com

Device Dimensions

Device Size Text, specify	0
Device Size Text, specify	0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981064648 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142488

FDA Product Code

ODP	Intervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[10889981064648]

Moist Heat or Steam Sterilization

[10889981064648]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-05-20

On-Brand Devices [SeaSpine Spacer System - Hollywood NanoMetalene]

10889981129644	Hollywood VI NM Implant Caddy, 30mm
10889981129637	Hollywood VI NM Implant Caddy, 27mm
10889981064662	Hollywood VI NM Implant, 11mm x 30mm x 16mm, Lordotic
10889981064655	Hollywood VI NM Implant, 11mm x 30mm x 15mm, Lordotic
10889981064648	Hollywood VI NM Implant, 11mm x 30mm x 14mm, Lordotic
10889981064631	Hollywood VI NM Implant, 11mm x 30mm x 13mm, Lordotic
10889981064624	Hollywood VI NM Implant, 11mm x 30mm x 12mm, Lordotic
10889981064617	Hollywood VI NM Implant, 11mm x 30mm x 11mm, Lordotic
10889981064600	Hollywood VI NM Implant, 11mm x 30mm x 10mm, Lordotic
10889981064594	Hollywood VI NM Implant, 11mm x 30mm x 9mm, Lordotic
10889981064587	Hollywood VI NM Implant, 11mm x 30mm x 8mm, Lordotic
10889981034856	Hollywood VI NM Implant, 11mm x 27mm x 16mm, Lordotic
10889981034849	Hollywood VI NM Implant, 11mm x 27mm x 15mm, Lordotic
10889981034832	Hollywood VI NM Implant, 11mm x 27mm x 14mm, Lordotic
10889981034825	Hollywood VI NM Implant, 11mm x 27mm x 13mm, Lordotic
10889981034818	Hollywood VI NM Implant, 11mm x 27mm x 12mm, Lordotic
10889981034801	Hollywood VI NM Implant, 11mm x 27mm x 11mm, Lordotic
10889981034795	Hollywood VI NM Implant, 11mm x 27mm x 10mm, Lordotic
10889981034788	Hollywood VI NM Implant, 11mm x 27mm x 9mm, Lordotic
10889981034771	Hollywood VI NM Implant, 11mm x 27mm x 8mm, Lordotic
00889981034750	Hollywood NM Sterile Implant, 11mm x 27mm x 18mm, Lordotic
00889981034743	Hollywood NM Sterile Implant, 11mm x 27mm x 17mm, Lordotic
00889981034736	Hollywood NM Sterile Implant, 11mm x 27mm x 16mm, Lordotic
00889981034729	Hollywood NM Sterile Implant, 11mm x 27mm x 15mm, Lordotic
00889981034712	Hollywood NM Sterile Implant, 11mm x 27mm x 14mm, Lordotic
00889981034705	Hollywood NM Sterile Implant, 11mm x 27mm x 13mm, Lordotic
00889981034699	Hollywood NM Sterile Implant, 11mm x 27mm x 12mm, Lordotic
00889981034682	Hollywood NM Sterile Implant, 11mm x 27mm x 11mm, Lordotic
00889981034675	Hollywood NM Sterile Implant, 11mm x 27mm x 10mm, Lordotic
00889981034668	Hollywood NM Sterile Implant, 11mm x 27mm x 9mm, Lordotic
00889981034651	Hollywood NM Sterile Implant, 11mm x 27mm x 8mm, Lordotic
00889981034644	Hollywood NM Sterile Implant, 11mm x 27mm x 7mm, Lordotic