FDA.reportPublic FDA data

Reform Ti HA Coated Pedicle Screw

Primary DI
00840019957533
Brand
Reform Ti HA Coated Pedicle Screw
Company
PRECISION SPINE, INC.
Model
39-HTC-1012
Catalog number
39-HTC-1012
Device description
Ø10.5 x 120mm Bone Screw, Cannulated
Published
2022-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151422000Reform Pedicle Screw SystemPrecision Spine, Inc.2015-08-21NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019957533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019957533008400199575338400199575330840019957533

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934909Reform Ti39-TD-555539-TD-55552019-10-04
00840019934916Reform Ti39-TD-556039-TD-55602019-10-04
00840019934923Reform Ti39-TD-652539-TD-65252019-10-04
00840019934930Reform Ti39-TD-653039-TD-65302019-10-04
00840019934947Reform Ti39-TD-653539-TD-65352019-10-04
00840019934954Reform Ti39-TD-654039-TD-65402019-10-04
00840019934961Reform Ti39-TD-654539-TD-65452019-10-04
00840019934978Reform Ti39-TD-655039-TD-65502019-10-04
00840019934985Reform Ti39-TD-655539-TD-65552019-10-04
00840019934992Reform Ti39-TD-656039-TD-65602019-10-04
00840019935005Reform Ti39-TD-753039-TD-75302019-10-04
00840019935012Reform Ti39-TD-753539-TD-75352019-10-04
00840019935029Reform Ti39-TD-754039-TD-75402019-10-04
00840019935036Reform Ti39-TD-754539-TD-75452019-10-04
00840019935043Reform Ti39-TD-755039-TD-75502019-10-04
00840019935050Reform Ti39-TD-755539-TD-75552019-10-04
00840019935067Reform Ti39-TD-756039-TD-75602019-10-04
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04

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Primary DI, Brand, Company table
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10888857598201Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598218Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598225Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598232Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
10888857598249Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24
00613994887955TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-09-17
00885074494722TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
00613994888143TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2015-08-05
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04546540147769XIA IIStryker CorporationNKB2014-12-08
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04546540147998XIA IStryker CorporationNKB2014-12-08
04546540148001XIA IIStryker CorporationNKB2014-12-08
04546540148018XIA IIStryker CorporationNKB2014-12-08
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04546540148735XIA IIStryker CorporationNKB2014-12-08
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