FDA.reportPublic FDA data

Interspinous Plate System

Primary DI
00815362022719
Brand
Interspinous Plate System
Company
PRECISION SPINE, INC.
Model
29-6100
Catalog number
29-6100
Device description
Reli™ SP Plus Instrument and Implant Case
Published
2019-04-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K160568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160568000Precision Spine Interspinous Plate SystemPrecision Spine, Inc.2016-05-04PEK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815362022719PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815362022719008153620227198153620227190815362022719

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019970907MD-Vue™ Lateral Access System54-TA-050054-TA-05002026-05-01
00840019970914MD-Vue™ Lateral Access System54-TA-060054-TA-06002026-05-01
00840019970921MD-Vue™ Lateral Access System54-TA-070054-TA-07002026-05-01
00840019970938MD-Vue™ Lateral Access System54-TA-080054-TA-08002026-05-01
00840019970945MD-Vue™ Lateral Access System54-TA-090054-TA-09002026-05-01
00840019970952MD-Vue™ Lateral Access System54-TA-100054-TA-10002026-05-01
00840019971133Reform Ti Modular39-SF-654539-SF-65452026-01-13
00840019971140Reform Ti Modular39-SF-655039-SF-65502026-01-13
00840019971157Reform Ti Modular39-SF-655539-SF-65552026-01-13
00840019971164Reform Ti Modular39-SF-656039-SF-65602026-01-13
00840019971171Reform Ti Modular39-SF-753039-SF-75302026-01-13
00840019971188Reform Ti Modular39-SF-753539-SF-75352026-01-13
00840019971195Reform Ti Modular39-SF-754039-SF-75402026-01-13
00840019971201Reform Ti Modular39-SF-754539-SF-75452026-01-13
00840019971218Reform Ti Modular39-SF-755039-SF-75502026-01-13
00840019971225Reform Ti Modular39-SF-755539-SF-75552026-01-13
00840019971232Reform Ti Modular39-SF-756039-SF-75602026-01-13
00840019971249Reform Ti Modular39-SF-757039-SF-75702026-01-13
00840019971256Reform Ti Modular39-SF-758039-SF-75802026-01-13
00840019971263Reform Ti Modular39-SF-853539-SF-85352026-01-13

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Primary DI, Brand, Company table
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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