FDA.reportPublic FDA data

Straight Neck Pattern 6-S

Primary DI
07640181160808
Brand
Straight Neck Pattern 6-S
Company
Keri Medical SA
Model
112-A50006
Published
2025-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument
SFAProsthesis, Finger, Semi-Constrained, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1
SFAProsthesis, Finger, Semi-Constrained, Metal/PolymerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P240020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P240020000TOUCH® CMC 1 ProsthesisKeri Medical SA2025-07-10SFA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640181160808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640181160808076401811608087640181160808

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480138827
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640181161270Straight AO Handle112-A910002025-07-21
07640181162833Kirschner wire Tube 16 cm Ø12mm000-A005002025-07-21
07640181163106Kirschner wire (Ø1.2 x 80 mm)000-A006502025-07-21
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
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
00840606185950ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185967ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185974ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185981ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606185998ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186001ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186018ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186025ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186032ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186049ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186056ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186063ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186070ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186087ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186094ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186100ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186117ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186124ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186131ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186148ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186155ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186162ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186179ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186186ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186193ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186209ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186247ALIFSPINAL ELEMENTS, INC.LXH2026-08-26
00840606186254ALIFSPINAL ELEMENTS, INC.LXH2026-08-26