SpaceFlex Hip Instrument Kit

GUDID 08058964726186

SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.

G21 SRL

Orthopaedic cement spacer mould

• Primary Device ID: 08058964726186
• NIH Device Record Key: a7276257-b923-41b0-921b-e2a544441611
• Commercial Distribution Discontinuation: 2019-12-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: SpaceFlex Hip Instrument Kit
• Version Model Number: 900008
• Company DUNS: 431529195
• Company Name: G21 SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	08058964726186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192041

FDA Product Code

• MBB: Bone Cement, Antibiotic

Sterilization

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

[08058964726186]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-12
• Device Publish Date: 2019-12-04

Devices Manufactured by G21 SRL

• 08058964727923 - SpaceFlex Acetabular Cup: 2023-04-19 The SpaceFlex Acetabular Cup consists of disposable cement spacer molds indicated for use to mold a temporary Acetabular cup rep
• 08058964726339 - Winch Kyphoplasty ( 15 mm) 11 Gauge Balloon Catheter: 2023-03-06 Kyphoplasty Balloon Catheter
• 08058964726407 - Winch Kyphoplasty ( 20 mm) 11 Gauge Balloon Catheter: 2023-03-06 Kyphoplasty Balloon Catheter
• 08058964726742 - FLEX DRILL 13G: 2022-06-10 Curette with curved distal end used to create a cavity inside the vertebra.
• 08058964724977 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
• 08058964726049 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
• 08058964726056 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen
• 08058964726063 - SpaceFlex Shoulder: 2021-03-15 Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder replacemen