FDA.report

Stablyx

Primary DI
00841506100333
Brand
Stablyx
Company
SKELETAL DYNAMICS L.L.C.
Model
STABLYX, CMC Implant, Sz. 3
Catalog number
STX-CMA-IS3
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KYIPROSTHESIS, WRIST, CARPAL TRAPEZIUM

Product Code Classifications

CodeDeviceSpecialtyClass
KYIProsthesis, Wrist, Carpal TrapeziumOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841506100333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506100333008415061003338415061003330841506100333

GMDN Terms

TermDefinition
Metacarpal prosthesisA sterile implantable device designed to replace the proximal end (base) of the first metacarpal of the thumb carpometacarpal (CMC) joint (articulation with the trapezium) typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device, made of one or several materials (e.g., carbon, graphite, metal); implantation may be performed with our without bone cement.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags

DUNS number
869056148
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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