FDA.reportPublic FDA data

Reform POCT System

Primary DI
00815362023969
Brand
Reform POCT System
Company
PRECISION SPINE, INC.
Model
55-PA-3518
Catalog number
55-PA-3518
Device description
Ø3.5 x 18mm Polyaxial Screw
Published
2019-05-03
Public version status
Update
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
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162300000
K172495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162300000Reform® POCT SystemPrecision Spine, Inc.2016-11-22NKG
K172495000Reform® POCT SystemPrecision Spine, Inc.2018-04-11NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815362023969PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815362023969008153620239698153620239690815362023969

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

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
00840019972895Navigated Instrument System70-SP-260070-SP-26002025-03-07
00840019973045Reform Ti Modular73-BK-010273-BK-01022025-03-05
00840019973069Reform Ti Modular73-BK-010473-BK-01042025-03-05
00840019972918Reform Ti Modular73-SP-260073-SP-26002025-01-24
00840019934800Reform Ti39-TC-109039-TC-10902019-10-04
00840019934817Reform Ti39-TC-100039-TC-10002019-10-04
00840019934824Reform Ti39-TC-101139-TC-10112019-10-04
00840019934831Reform Ti39-TC-101239-TC-10122019-10-04
00840019935319Reform Ti39-TD-951239-TD-95122019-10-07
00840019935364Reform Ti39-TD-106039-TD-10602019-10-07
00840019934725Reform Ti39-TC-951239-TC-95122019-09-25
00840019934732Reform Ti39-TC-104039-TC-10402019-09-25
00840019934749Reform Ti39-TC-104539-TC-10452019-09-25
00840019934756Reform Ti39-TC-105039-TC-10502019-09-25
00840019934763Reform Ti39-TC-105539-TC-10552019-09-25
00840019934770Reform Ti39-TC-106039-TC-10602019-09-25
00840019934787Reform Ti39-TC-107039-TC-10702019-09-25
00840019934794Reform Ti39-TC-108039-TC-10802019-09-25
00840019934251Reform Ti39-TC-552539-TC-55252019-09-10
00840019934268Reform Ti39-TC-553039-TC-55302019-09-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000992576INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-17
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