Acetabular Shell Alignment Attachment - Enztec 1080-0-1601

GUDID 09421038411636

A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09421038411636
• NIH Device Record Key: c5d2a2b4-832a-441d-a214-1161fede07bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acetabular Shell Alignment Attachment - Enztec
• Version Model Number: 1080-0-1601
• Catalog Number: 1080-0-1601
• Company DUNS: 592616445
• Company Name: ENZTEC LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421038411636 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

[09421038411636]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-29
• Device Publish Date: 2025-12-19

Devices Manufactured by ENZTEC LIMITED

• 09421028110624 - Enztec Femoral Impactor - DJO: 2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028110631 - DJO Femoral Impactor Head: 2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028112536 - Enztec Classic OCI - Trinket 5/16-24 UNF-02: 2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028113540 - Enztec Classic OCI - Trinket 3/8-16 UNC-01: 2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028113557 - Enztec Classic OCI - Trinket 5/16-24 UNF-01: 2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028113571 - Enztec Classic OCI - Trinket 3/8-24 UNF-01: 2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410516 - ATTUNE FEMORAL IMPACTOR: 2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421038410523 - ATTUNE FEMORAL IMPACTOR HEAD: 2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure