Identity
- Trade Name
- ContourFlex™ Gluteal Implant, Smooth (Round) FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Gluteal Implant FDA UDI
- Model / Reference
- Size: 13.5cm x 13.5cm x 4.5cm FDA UDI
- Description
- Gluteal Implant FDA UDI
Identifiers
- Catalog Number
- CCB5-S-55 FDA UDI
- Primary DI / UDI-DI
- M724CCB5S551 FDA UDI
- 510(k) Number
- K982688 FDA UDI
- FDA Product Code
- MIB FDA UDI
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silicone-block tissue reconstructive material
ContourFlex™ Gluteal Implant, Smooth (Round) by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Silicone-block tissue reconstructive material.
- Gluteal Implant — Aart · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Calf Implant — Aart · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Gluteal Implant — Hanson Medical, Inc. · Class II
- Silicone Block — International Medical Devices, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
Cleared under the same submission
K982688 also covers:
- Calf Implant, Smooth SDM — Implantech Associates, Inc.
- Calf Implant, Smooth SDM — Implantech Associates, Inc.
- Calf Implant, Smooth SDM — Implantech Associates, Inc.
- Calf Implant, Smooth SDM — Implantech Associates, Inc.
- Calf Implant, Smooth SDM — Implantech Associates, Inc.
- Calf Implant, Textured SDM — Implantech Associates, Inc.
- Calf Implant, Textured SDM — Implantech Associates, Inc.
- Calf Implant, Textured SDM — Implantech Associates, Inc.
- Calf Implant, Textured SDM — Implantech Associates, Inc.
- Calf Implant, Textured SDM — Implantech Associates, Inc.
- Calf Implant, Textured, (Carlsen) SDM — Implantech Associates, Inc.
- Calf Implant, Textured, (Carlsen) SDM — Implantech Associates, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (1)
- FDA UDI 17be4927-627c-4d63-9cea-7dd7f7b9eb53 36 fields · synced Jun 9, 2026