FDA.reportPublic FDA data

Reform Ti Modular

Primary DI
00840019971386
Brand
Reform Ti Modular
Company
PRECISION SPINE, INC.
Model
39-SF-9560
Catalog number
39-SF-9560
Device description
Modular Fenestrated Bone-Screw - 9.5 mm x 60 mm
Published
2026-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NOKMaterial, External Aesthetic Restoration, No Adhesive
PMLBone Cement, Posterior Screw Augmentation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOKMaterial, External Aesthetic Restoration, No AdhesiveGeneral, Plastic Surgery1
PMLBone Cement, Posterior Screw AugmentationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242297000Reform Pedicle Screw SystemPrecision Spine, Inc.2024-12-17NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019971386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019971386008400199713868400199713860840019971386

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation implant/sterilization container setA collection of non-sterile, implantable components of an internal spinal fixation assembly (e.g., plates, rods, screws, connectors, and/or hooks) packaged within a reusable sterilization container (i.e., all under the same product code) to be sterilized prior to implantation. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants may be resterilised for subsequent implantation in another patient. Instruments intended to facilitate implantation may be packaged with the set. This is a reusable device which includes single-use implants.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Donation ID number
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640172554227VADER Pedicle System, Nut Screw, Tiicotec AGPML2026-04-30
07640172554234VADER Pedicle System, Cross-Link, Ti, 30/34 mmicotec AGPML2026-04-30
07640172554241VADER Pedicle System, Cross-Link, Ti, 33/42 mmicotec AGPML2026-04-30
07640172554258VADER Pedicle System, Cross-Link, Ti, 40/53 mmicotec AGPML2026-04-30
07640172554265VADER Pedicle System, Cross-Link, Ti, 50/70 mmicotec AGPML2026-04-30
07640172553909icotec Systems, Saw bladeicotec AGPML2025-09-01
07640172553848"icotec Systems, Handle, 1/4"" Coupling"icotec AGPML2025-08-13
07640172553855icotec Systems, Fixation deviceicotec AGPML2025-08-13
07640172553862icotec Systems, Deburring toolicotec AGPML2025-08-13
07640172553879icotec Systems, Handle for deburrer, M6icotec AGPML2025-08-13
07640172552537VADER Pedicle System, Trephine for Ø 4.5 mm Screw, Ø 4.5 mmicotec AGPML2025-06-02
07640172552858VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mmicotec AGPML2025-03-05
07640172552865VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mmicotec AGPML2025-03-05
07640172552872icotec Systems, Torque-Limiting Adapter, 3.5 Nmicotec AGPML2025-03-05
07640172552889VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nmicotec AGPML2025-03-05
07640172553572VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nmicotec AGPML2025-03-05
07640172552742VADER Pedicle System, VADER Pedicle System Rod-2-size, Container, completeicotec AGPML2023-09-08
07640305165481PERLA® TL MISSpineArt SAPML2023-06-27
07640305165504PERLA® TL MISSpineArt SAPML2023-06-27
07640305165511PERLA® TL MISSpineArt SAPML2023-06-27
07640172551950VADER Pedicle System, Saw bladeicotec AGPML2023-01-13
07640172552285VADER Pedicle System, Trephine for Ø 5.5 mm Screw, Ø 5.5 mmicotec AGPML2023-01-13
07640172552292VADER Pedicle System, Trephine for Ø 6.5 mm Screw, Ø 6.5 mmicotec AGPML2023-01-13
07640172552308VADER Pedicle System, Trephine for Ø 7.5 mm Screw, Ø 7.5 mmicotec AGPML2023-01-13
07640172551967"VADER Pedicle System, Handle, 1/4"" Coupling"icotec AGPML2023-01-13
07640172551981VADER Pedicle System, Deburring toolicotec AGPML2023-01-13
07640172551998VADER Pedicle System, Trial rod, flexible, Ø 5.5 mm; L = 300 mmicotec AGPML2023-01-13
07640172552001VADER Pedicle System, Template for HT S-rodsicotec AGPML2023-01-13
07640172552018VADER Pedicle System, Template for TL S-rodsicotec AGPML2023-01-13
07640172552025VADER Pedicle System, Template for L S-rodsicotec AGPML2023-01-13