FDA.reportPublic FDA data

PRCT2

Primary DI
03701037310892
Brand
PRCT2
Company
FX SOLUTIONS
Model
100-0109
Catalog number
100-0109
Device description
PRCT II PLATE TA6V LEFT 9 HOLES
Published
2021-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143721000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143721000PRCT2Fx Solutions2015-08-27HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701037310892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701037310892037010373108923701037310892

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
263076196
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701037320433ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-0074951-00742026-08-17
03701037313855ORTHOPEDIC MANUAL SURGICAL INSTRUMENT961-0017961-00172026-06-26
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8803951-88032026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8806951-88062026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8809951-88092026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8812951-88122026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8815951-88152026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-8818951-88182026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9803951-98032026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9806951-98062026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9809951-98092026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9812951-98122026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9815951-98152026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9818951-98182026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9909951-99092026-06-26
03701037316542ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9912951-99122026-06-26
03701037316559ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9915951-99152026-06-26
03701037316566ORTHOPEDIC MANUAL SURGICAL INSTRUMENT951-9918951-99182026-06-26
03701037300718HUMELOCK903-4036903-40362026-06-25
03701037307007Humelock II Cementless Shoulder System926-1025926-10252026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188132452Tools - TWFTrimed, INC.HRS2026-08-18
00842188132230Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132247Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132254Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132261Non-Spanning Wrist FusionTrimed, INC.HRS2026-08-17
00842188132445Tools - TWFTrimed, INC.HRS2026-08-17
00193982096274ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096298ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982096311ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101909ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101923ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982101947ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158323ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158378ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158422ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158477ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158521ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158576ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158620ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158675ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158729ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158774ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982158828ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167615ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167660ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167714ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167769ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167813ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167868ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14
00193982167912ANTHEMGLOBUS MEDICAL, INC.HRS2026-08-14