FDA.reportPublic FDA data

Offset Neck Pattern 8-M

Primary DI
07640181160846
Brand
Offset Neck Pattern 8-M
Company
Keri Medical SA
Model
112-A51508
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
07640181160846PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640181160846076401811608467640181160846

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
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
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
00850078396389TruTORQ Offset T-Handle Sterile, Single UseEca Medical InstrumentsLXH2026-10-20
10810128464144Tendon Stripper, ClosedT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16