FDA.report

IJS

Primary DI
00841506114019
Brand
IJS
Company
SKELETAL DYNAMICS L.L.C.
Model
IJS
Catalog number
IJS-EAP-F30
Device description
IJS-E Axis Pin Female, 30mm
Published
2023-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
OZIInternal hinged elbow fixator

Product Code Classifications

CodeDeviceSpecialtyClass
OZIInternal Hinged Elbow FixatorOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841506114019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506114019008415061140198415061140190841506114019

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00841506141480Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, RightPUPF-8SPR2026-03-05
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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
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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 DIBrandCompanyProduct codePublished
00841506107271IJS-ESKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506109107IJS-ESKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506109138IJS-ESKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506109305IJS-ESKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506109374IJS-ESKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506114323IJS-E (Twin)SKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506132921IJSSKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506132945IJSSKELETAL DYNAMICS L.L.C.OZI2023-06-20
00841506104898IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104904IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104911IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104928IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104935IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104942IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104959IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104966IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104973IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104980IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506104997IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105000IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105017IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105024IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105031IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105048IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105055IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105062IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105079IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105086IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105093IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30
00841506105109IJSSKELETAL DYNAMICS L.L.C.OZI2017-10-30