FDA.reportPublic FDA data

Spinous Process System

Primary DI
10889981096199
Brand
Spinous Process System
Company
Seaspine Orthopedics Corporation
Model
95-3020
Catalog number
95-3020
Device description
Inserter, Spinous Process Spacer
Published
2015-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEKSpinous process plate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEKSpinous Process PlateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121924000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121924000INTEGRA INTERSPINOUS PROCESS SYSTEMSeaspine, Inc.2013-09-04PEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981096199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998109619910889981096199

GMDN Terms#

Term, Definition table
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 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889981080877Malibu91-214791-21472016-05-02
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
M9431002200000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002210000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002220000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002230000Minuteman Spinal Simplicity, LLCPEK2026-02-23
M9431002240000Minuteman Spinal Simplicity, LLCPEK2026-02-23
10889981146498GeneralSeaspine Orthopedics CorporationPEK2025-12-19
07640185341678ROMEO 2 PAD INSTRUMENTATIONSpineArt SAPEK2025-11-11
B1830712181100KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181120KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181140KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712181160KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200100KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200120KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200140KeyLift™FLOSPINE LLCPEK2025-02-03
B1830712200160KeyLift™FLOSPINE LLCPEK2025-02-03
10889981146412NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146436NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146443NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146450NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146467NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146474NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981146481NewPortSeaspine Orthopedics CorporationPEK2024-12-11
10889981096298GeneralSeaspine Orthopedics CorporationPEK2024-06-11
10889981096304GeneralSeaspine Orthopedics CorporationPEK2024-06-11
10889981096311GeneralSeaspine Orthopedics CorporationPEK2024-06-11
00190837137090Aileron TRXLife Spine, Inc.PEK2022-07-11
M9431001040000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001000000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001010000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13
M9431001020000Minuteman G5Spinal Simplicity, LLCPEK2022-05-13