Paragon 28 Bone Wedge System AOCWO-16-5

GUDID 00889795120199

Additive Orthopaedics Organic Cotton Wedge, 16-5

PARAGON 28, INC.

Metallic osteotomy fusion cage, non-customized

• Primary Device ID: 00889795120199
• NIH Device Record Key: e1e80536-d750-4c27-8cc2-5214cfad8294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon 28 Bone Wedge System
• Version Model Number: AOCWO-16-5
• Catalog Number: AOCWO-16-5
• Company DUNS: 042961576
• Company Name: PARAGON 28, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889795120199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153207

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

[00889795120199]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-04
• Device Publish Date: 2023-06-26

On-Brand Devices [Paragon 28 Bone Wedge System]

• 00889795121400: Additive Orthopaedics General Trial Caddy Lid
• 00889795121394: Additive Orthopaedics General Trial Caddy Base
• 00889795121387: Additive Orthopaedics Cotton Wedge Trial, 20-8
• 00889795121370: Additive Orthopaedics Cotton Wedge Trial, 18-8
• 00889795121363: Additive Orthopaedics Cotton Wedge Trial, 16-8
• 00889795121356: Additive Orthopaedics Cotton Wedge Trial, 20-10
• 00889795121349: Additive Orthopaedics Cotton Wedge Trial, 18-10
• 00889795121332: Additive Orthopaedics Cotton Wedge Trial, 16-10
• 00889795121301: Additive Orthopaedics Organic Cotton Wedge Trial, 20-8
• 00889795121295: Additive Orthopaedics Organic Cotton Wedge Trial, 20-7
• 00889795121288: Additive Orthopaedics Organic Cotton Wedge Trial, 20-6
• 00889795121271: Additive Orthopaedics Organic Cotton Wedge Trial, 20-5
• 00889795121189: Additive Orthopaedics Organic Cotton Wedge Trial, 16-8
• 00889795121172: Additive Orthopaedics Organic Cotton Wedge Trial, 16-7
• 00889795121165: Additive Orthopaedics Organic Cotton Wedge Trial, 16-6
• 00889795121158: Additive Orthopaedics Organic Cotton Wedge Trial, 16-5
• 00889795120830: AO NON-LCKG SCW 3.0MM X 30MM
• 00889795120823: AO NON-LCKG SCW 3.0MM X 28MM
• 00889795120816: AO NON-LCKG SCW 3.0MM X 26MM
• 00889795120809: AO NON-LCKG SCW 3.0MM X 24MM
• 00889795120793: AO NON-LCKG SCW 3.0MM X 22MM
• 00889795120786: AO NON-LCKG SCW 3.0MM X 20MM
• 00889795120779: AO NON-LCKG SCW 3.0MM X 18MM
• 00889795120762: AO NON-LCKG SCW 3.0MM X 16MM
• 00889795120755: AO NON-LCKG SCW 3.0MM X 14MM
• 00889795120748: AO NON-LCKG SCW 3.0MM X 12MM
• 00889795120731: AO LCKG SCW 3.0MM X 30MM
• 00889795120724: AO LCKG SCW 3.0MM X 28MM
• 00889795120717: AO LCKG SCW 3.0MM X 26MM
• 00889795120700: AO LCKG SCW 3.0MM X 24MM
• 00889795120694: AO LCKG SCW 3.0MM X 22MM
• 00889795120687: AO LCKG SCW 3.0MM X 20MM
• 00889795120670: AO LCKG SCW 3.0MM X 18MM
• 00889795120663: AO LCKG SCW 3.0MM X 16MM
• 00889795120656: AO LCKG SCW 3.0MM X 14MM
• 00889795120649: AO LCKG SCW 3.0MM X 12MM
• 00889795120625: AO LCKG EVANS BONE SEG 22 X 22 X 8
• 00889795120618: AO LCKG EVANS BONE SEG 22 X 22 X 10
• 00889795120601: AO LCKG EVANS BONE SEG 20 X 20 X 8
• 00889795120595: AO LCKG EVANS BONE SEG 20 X 20 X12
• 00889795120588: AO LCKG EVANS BONE SEG 20 X 20 X10
• 00889795120564: AO LCKG EVANS BONE SEG 18 X 18 X12
• 00889795120557: AO LCKG EVANS BONE SEG 18 X 18 X10
• 00889795120540: AO 2.2MM DRILL BIT
• 00889795120533: AO 2.0MM DRILL BIT
• 00889795120526: AO EVANS BONE SEG- 22 X 22 X 8
• 00889795120519: AO EVANS BONE SEG- 22 X 22 X 12
• 00889795120502: AO EVANS BONE SEG- 22 X 22 X 10
• 00889795120496: AO EVANS BONE SEG- 20 X 20 X 8
• 00889795120489: AO EVANS BONE SEG- 20 X 20 X 12