FDA.reportPublic FDA data

Spinous Process System

Primary DI
10889981129705
Brand
Spinous Process System
Company
Seaspine Orthopedics Corporation
Model
95-3025
Catalog number
95-3025
Device description
Plate Inserter, Spinous Process Spacer
Published
2016-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10889981129705PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998112970510889981129705

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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
10889981442187REEF LRL2-100608RL2-1006082026-06-19
10889981443344REEF LRL3-109002RL3-1090022026-06-19
10889981326234RegattaRP1-200200RP1-2002002025-01-17
10889981326777RegattaRP1-000308RP1-0003082025-01-17
10889981326784RegattaRP1-000310RP1-0003102025-01-17
10889981326791RegattaRP1-000312RP1-0003122025-01-17
10889981326807RegattaRP1-000314RP1-0003142025-01-17
10889981326814RegattaRP1-000316RP1-0003162025-01-17
10889981326821RegattaRP1-000318RP1-0003182025-01-17
10889981326838RegattaRP1-000320RP1-0003202025-01-17
10889981329969RegattaRP3-209300RP3-2093002025-01-17
10889981330002WaveForm LWL4-184015WL4-1840152025-01-17
10889981330026WaveForm LWL4-184515WL4-1845152025-01-17
10889981330040WaveForm LWL4-185015WL4-1850152025-01-17
10889981330064WaveForm LWL4-185515WL4-1855152025-01-17
10889981330088WaveForm LWL4-186015WL4-1860152025-01-17
10889981330101WaveForm LWL4-284015WL4-2840152025-01-17
10889981330125WaveForm LWL4-284515WL4-2845152025-01-17
10889981330149WaveForm LWL4-285015WL4-2850152025-01-17
10889981330163WaveForm LWL4-285515WL4-2855152025-01-17

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