FDA.reportPublic FDA data

KeriFlex

Primary DI
07640181160600
Brand
KeriFlex
Company
Keri Medical SA
Model
210-P10020
Published
2022-10-20
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
KYJProsthesis, Finger, Constrained, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYJProsthesis, Finger, Constrained, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211385000KeriFlex® MCP and PIP Finger Joint ProsthesesKeri Medical SA2022-07-27KYJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640181160600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640181160600076401811606007640181160600

GMDN Terms#

Term, Definition table
TermDefinition
Metacarpophalangeal joint prosthesis, one-pieceAn implantable artificial substitute for the metacarpophalangeal (MCP) joint(s) of the hand (finger) which has been damaged by rheumatoid, degenerative, or traumatic arthritis. It consists of a single flexible across-the-joint component (one-piece) made from either a silicone elastomer or a combination of polypropylene and polyester materials. The flexible across-the-joint component may be covered with a silicone rubber sleeve.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
480138827
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640181162833Kirschner wire Tube 16 cm Ø12mm000-A005002025-07-21
07640181163106Kirschner wire (Ø1.2 x 80 mm)000-A006502025-07-21
07640181160808Straight Neck Pattern 6-S112-A500062025-07-21
07640181160815Straight Neck Pattern 8-M112-A500082025-07-21
07640181160822Straight Neck Pattern 10-L112-A500102025-07-21
07640181160839Offset Neck Pattern 6-S112-A515062025-07-21
07640181160846Offset Neck Pattern 8-M112-A515082025-07-21
07640181160853Offset Neck Pattern 10-L112-A515102025-07-21
07640181160860Spherical Cup Pattern Ø9112-A200002025-07-21
07640181160877Spherical Cup Pattern Ø10112-A200102025-07-21
07640181160884Conical Cup Pattern Ø9112-A201002025-07-21
07640181160891Conical Cup Pattern Ø10112-A201102025-07-21
07640181160921K-Wire Centering Guide112-A280002025-07-21
07640181161003Stem Pattern 0112-A301002025-07-21
07640181161010Stem Pattern 1112-A301012025-07-21
07640181161027Stem Pattern 2112-A301022025-07-21
07640181161034Stem Pattern 3112-A301032025-07-21
07640181161041Stem Pattern 4112-A301042025-07-21
07640181161058Stem Pattern XS112-A301052025-07-21
07640181161256Forked retractor112-A002002026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08057717554519DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554526DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554533DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554540DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554557DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554564DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554571DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554588DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
08057717554595DIGITALIS SpacerBRM EXTREMITIES SRLKYJ2024-05-13
00885556856871Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856888Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856895Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856901Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856918Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856925Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556856963Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856970Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856987Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556856994Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857007Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857014Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857021Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857038Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857045Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857052Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857069Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857076Ascension MCP Joint ReplacementSmith & Nephew, Inc.KYJ2022-12-22
00885556857083Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857090Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22
00885556857106Silicone MCPSmith & Nephew, Inc.KYJ2022-12-22