FDA.reportPublic FDA data

SeaSpine Spacer System - Pacifica

Primary DI
10889981088408
Brand
SeaSpine Spacer System - Pacifica
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
93-3408
Catalog number
93-3408
Device description
Box Cutter 11mm x 15mm
Published
2016-03-31
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCUTTER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981088408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998108840810889981088408

GMDN Terms#

Term, Definition table
TermDefinition
Bone fileA hand-held, manually-operated, instrument that has various forms of fine ridged cutting surfaces along part of or all of its working end that is used for cutting and smoothing (filing) bone tissue. It is made of high-grade steel and may be a one-piece instrument with a handle at the proximal end. The distal end may be flat or profiled (e.g., flat on one side and convex on the other). This device is typically used in orthopaedics, plastic surgery and dentistry. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
079840876
Device count
1
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981137472Shoreline ACS86-001186-00112016-09-30
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03662663129053Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCFZT2026-02-11
10889981087968GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087975GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087982GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981095970GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981106058CoralSeaspine Orthopedics CorporationFZT2025-12-19
10889981123932GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981259921NorthStarSeaspine Orthopedics CorporationFZT2025-12-19
03662663278096Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-18
03662663217699Vail OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-12-17
03662663266635Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266642Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266659Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266666Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266673Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266680Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266697Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266703Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266710Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266727Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266734Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266741Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266758Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266765Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266772Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278799Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278805Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278812Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278829Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278836Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16