FDA.reportPublic FDA data

Spinous Process Plate, 14mm

Primary DI
00810131880828
Brand
Spinous Process Plate, 14mm
Company
Surgentec, LLC
Model
SR08-4614
Published
2025-01-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101525000
K110367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101525000PIONEER SPINOUS PROCESS FUSION PLATEPioneer Surgical Technology2010-10-22KWP
K110367000PIONEER SPINAL PROCESS FUSION PLATEPioneer Surgical Technology, Inc.2011-03-23KWP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810131880828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810131880828008101318808288101318808280810131880828

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
004095409
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810131880736OsteoFlo Synthetic HydroPutty HFP - 1ccOHFP-S-012025-06-10
00810131880743OsteoFlo Synthetic HydroPutty HFP - 3ccOHFP-S-032025-06-10
00810131880750OsteoFlo Synthetic HydroPutty HFP - 6ccOHFP-S-062025-06-10
00810131880767OsteoFlo Synthetic HydroPutty HFP - 12ccOHFP-S-122025-06-10
00810131881139OsteoFlo Synthetic Nanoputty Syringe - 5cc - IOSALONP-S-05 - IB2025-06-10
00810131881146OsteoFlo Synthetic Nanoputty Syringe - 10cc - IOSALONP-S-10 - IB2025-06-10
00810131881153OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881160OsteoFlo Synthetic Nanoputty Cartridge - 10cc - IOSALONP-T-1000-IB2025-06-10
00810131881177OsteoFlo HydroPutty Synthetic HFP - 6cc Labeled - IOSALOHFP-S-06-IB2025-06-10
00810131881184OsteoFlo HydroPutty Synthetic HFP - 12cc Labeled - IOSALOHFP-S-12-IB2025-06-10
00858406007648OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 5ccONP-K-5002025-06-10
00858406007655OsteoFlo Synthetic Nanoputty Cartridge Graftgun Combo Kit - 10ccONP-K-10002025-06-10
00858406007662OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 1ccONP-U-012025-06-10
00858406007679OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 2.5ccONP-U-022025-06-10
00858406007686OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 5ccONP-U-052025-06-10
00858406007693OsteoFlo Synthetic Nanoputty Syringe Graftgun Combo Kit - 10ccONP-U-102025-06-10
00810131880545Global Tip Adapter - LongGG-NTA-122025-03-14
00810131881191Global Tip Adapter - NarrowGG-NTA-142025-03-14
00810131881207Bullet Global Tip AdapterGG-NTA-132025-03-14
00858406007150Bullet Tip AdapterGG-NTA-032025-03-14

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