FDA.reportPublic FDA data

Reform Ti

Primary DI
00840019978460
Brand
Reform Ti
Company
PRECISION SPINE, INC.
Model
39-RM-5520
Catalog number
39-RM-5520
Device description
ø5.5mm x 20mm Reduction Uniplanar Screw
Published
2026-11-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KWPAppliance, Fixation, Spinal Interlaminal
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200303000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200303000Reform Pedicle Screw SystemPrecision Spine2020-05-19NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019978460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019978460008400199784608400199784600840019978460

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019978453Reform Ti39-RM-454539-RM-45452026-11-04
00840019978477Reform Ti39-RM-552539-RM-55252026-11-04
00840019936798Sure-Lok Extended Tab Pedicle Screw System48-2000-CA48-2000-CA2019-09-03
00840019922661Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0004HXI-48-00042019-03-28
00840019922692Sure-Lok Extended Tab Pedicle Screw System48-200048-20002019-03-28
00840019922630Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0001HXI-48-00012019-03-27
00840019922647Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0002HXI-48-00022019-03-27
00840019922654Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0003HXI-48-00032019-03-27
00840019922678Sure-Lok Extended Tab Pedicle Screw SystemHXI-48-0005HXI-48-00052019-03-27
00840019922685Sure-Lok Extended Tab Pedicle Screw System48-110048-11002019-03-27
00840019925631PSS SystemHXI-SL-0001*HXI-SL-0001*2019-03-27
00840019978156Reform Ti39-TM-454539-TM-45452026-10-19
00840019978163Reform Ti39-TM-552039-TM-55202026-10-19
00840019978170Reform Ti39-TM-552539-TM-55252026-10-19
00840019978187Reform Ti39-TM-553039-TM-55302026-10-19
00840019978194Reform Ti39-TM-553539-TM-55352026-10-19
00840019978200Reform Ti39-TM-554039-TM-55402026-10-19
00840019978217Reform Ti39-TM-554539-TM-55452026-10-19
00840019978224Reform Ti39-TM-555039-TM-55502026-10-19
00840019978231Reform Ti39-TM-555539-TM-55552026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157124618ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124625ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124632ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124649ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124656ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124663ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124670ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124687ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124694ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124700ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124717ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124724ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124731ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124748ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124755ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124762ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124779ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124786ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124793ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124809ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124816ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124823ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124830ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124847ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124854ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124861ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124878ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124885ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124892ZAVATION SCREWZavation LLCNKB2026-11-04
00197157124908ZAVATION SCREWZavation LLCNKB2026-11-04