FDA.reportPublic FDA data

Patient-Fitted TMJ Reconstructive Prosthesis System

Primary DI
07613327626643
Brand
Patient-Fitted TMJ Reconstructive Prosthesis System
Company
TMJ Solutions, Inc.
Model
60-0120
Device description
Implant Stabilizer
Published
2023-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B0046001200PreviousHIBCC0
07613327626643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327626643076133276266437613327626643

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
805-650-3391lorena.lundeen@stryker.com

Regulatory Flags#

DUNS number
035877922
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327626551Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0102023-09-11
07613327626568Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0262023-09-11
07613327626575Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0202023-09-11
07613327626605Patient-Fitted TMJ Reconstructive Prosthesis SystemCHG0242023-09-11
07613327626650Patient-Fitted TMJ Reconstructive Prosthesis System61-20062023-09-11
07613327626674Patient-Fitted TMJ Reconstructive Prosthesis System61-20122023-09-11
07613327626681Patient-Fitted TMJ Reconstructive Prosthesis System65-20052023-09-11
07613327626698Patient-Fitted TMJ Reconstructive Prosthesis System61-20082023-09-11
07613327626704Patient-Fitted TMJ Reconstructive Prosthesis System61-20162023-09-11
07613327626711Patient-Fitted TMJ Reconstructive Prosthesis System65-20062023-09-11
07613327626728Patient-Fitted TMJ Reconstructive Prosthesis System65-20082023-09-11
07613327626742Patient-Fitted TMJ Reconstructive Prosthesis System61-20102023-09-11
07613327626759Patient-Fitted TMJ Reconstructive Prosthesis System65-20162023-09-11
07613327626766Patient-Fitted TMJ Reconstructive Prosthesis System65-20122023-09-11
07613327626773Patient-Fitted TMJ Reconstructive Prosthesis System61-20052023-09-11
07613327626780Patient-Fitted TMJ Reconstructive Prosthesis System65-20142023-09-11
07613327626797Patient-Fitted TMJ Reconstructive Prosthesis System65-20102023-09-11
07613327626803Patient-Fitted TMJ Reconstructive Prosthesis System61-23102023-09-11
07613327626810Patient-Fitted TMJ Reconstructive Prosthesis System61-23142023-09-11
07613327626827Patient-Fitted TMJ Reconstructive Prosthesis System61-23082023-09-11

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