FDA.reportPublic FDA data

Stablyx

Primary DI
00841506103112
Brand
Stablyx
Company
SKELETAL DYNAMICS L.L.C.
Model
STABLYX, CMC Impactor
Catalog number
STX-CMA-IMP
Published
2015-10-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841506103112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506103112008415061031128415061031120841506103112

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841506141442Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 7 Slot, RightPUPF-7SR2026-03-05
00841506141459Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 7 Slot, LeftPUPF-7SL2026-03-05
00841506141466Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot, RightPUPF-8SR2026-03-05
00841506141473Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot, LeftPUPF-8SL2026-03-05
00841506141480Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, RightPUPF-8SPR2026-03-05
00841506141497Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, LeftPUPF-8SPL2026-03-05
00841506117621GeminusRadial Hook Plate Guide, RightGMN-HPG-RR2026-01-21
00841506117638GeminusRadial Hook Plate Guide, LeftGMN-HPG-RL2026-01-21
00841506117645GeminusUlnar Hook Plate GuideGMN-HPG-UB2026-01-21
00841506117652GeminusGEMINUS Hook Plate, Radial, RightGMN-HP-RR2026-01-21
00841506117669GeminusGEMINUS Hook Plate, Radial, LeftGMN-HP-RL2026-01-21
00841506142333GeminusButtress Button, 6.35mm Round, 0.6mm x 152mmBB-RND-012026-01-21
00841506142340GeminusWire Guide, Tapered, 0.9mm x 152mmWG-ST-091522026-01-21
00841506142364GeminusWire Cutter, Small, AngledINST-WC-SM2026-01-21
00841506142708GeminusMarginal Fragment ModuleGMN-MF-MOD2026-01-21
00841506112763ProteanCMC Osteotomy Cutting GuidePRT-CTG-CMC2025-12-01
00841506113050ProteanPROTEAN Fragment Plate, CMCPRT-MFP-CMC2025-12-01
00841506136028ProteanScrew, Variable Angle Locking, 2.5mm x 6mm, CoCrVAL-25060-CC2025-12-01
00841506136035ProteanScrew, Variable Angle Locking, 2.5mm x 7mm, CoCrVAL-25070-CC2025-12-01
00841506136042ProteanScrew, Variable Angle Locking, 2.5mm x 8mm, CoCrVAL-25080-CC2025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868150876Affixus®Zimmer, Inc.HSB2026-03-20
00887868150333Affixus®Zimmer, Inc.HSB2026-03-19
00887868150340Affixus®Zimmer, Inc.HSB2026-03-19
00887868150357Affixus®Zimmer, Inc.HSB2026-03-19
00887868150364Affixus®Zimmer, Inc.HSB2026-03-19
00887868150371Affixus®Zimmer, Inc.HSB2026-03-19
00887868150388Affixus®Zimmer, Inc.HSB2026-03-19
00887868150395Affixus®Zimmer, Inc.HSB2026-03-19
00887868150401Affixus®Zimmer, Inc.HSB2026-03-19
00887868150555Affixus®Zimmer, Inc.HSB2026-03-19
00887868150562Affixus®Zimmer, Inc.HSB2026-03-19
00887868150579Affixus®Zimmer, Inc.HSB2026-03-19
00887868150586Affixus®Zimmer, Inc.HSB2026-03-19
00887868150593Affixus®Zimmer, Inc.HSB2026-03-19
00887868150609Affixus®Zimmer, Inc.HSB2026-03-19
00887868150616Affixus®Zimmer, Inc.HSB2026-03-19
00887868150883Affixus®Zimmer, Inc.HSB2026-03-19
00887868150890Affixus®Zimmer, Inc.HSB2026-03-19
00887868150906Affixus®Zimmer, Inc.HSB2026-03-19
00887868150913Affixus®Zimmer, Inc.HSB2026-03-19
00887868150920Affixus®Zimmer, Inc.HSB2026-03-19
00889024700253Affixus®Zimmer, Inc.HSB2026-03-19
00889024700260Affixus®Zimmer, Inc.HSB2026-03-19
00889024700277Affixus®Zimmer, Inc.HSB2026-03-19
00889024700284Affixus®Zimmer, Inc.HSB2026-03-19
00889024700291Affixus®Zimmer, Inc.HSB2026-03-19
00888867463363Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529069Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529076Arthrex®ARTHREX, INC.HSB2026-03-16
00888867529137Arthrex®ARTHREX, INC.HSB2026-03-16