Identity
- Trade Name
- COMPRESS DEVICE FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Model / Reference
- 178399 FDA UDI
Identifiers
- Catalog Number
- 178399 FDA UDI
- Primary DI / UDI-DI
- 00880304452497 FDA UDI
- FDA Product Code
- JDI FDA UDIMEH FDA UDIKWY FDA UDILZO FDA UDIKRO FDA UDILPH FDA UDIKWZ FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3353 FDA UDI888.3390 FDA UDI888.3510 FDA UDI888.3358 FDA UDI888.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
No
FDA UDI
Category: Orthopaedic implant-instrument extension adaptor, reusable
Compress Device by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant-instrument extension adaptor, reusable.
- Truliant CC — Exactech, Inc. · Class II
- Adaptor Delta Cups — Limacorporate · Class II
- Jet-X — Smith & Nephew, Inc. · Class II
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- ACS® — implantcast GmbH · Class I
- Shukla Copter S9COPTER — Shukla Medical · Class I
- HEX DRIVE ATRAUMATIC RMR — Zimmer, Inc. · Class I
- PB Uni tibial impaction adapter — implantcast GmbH · Class I
Cleared under the same submission
K031804 also covers:
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
K043547 also covers:
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- COMPRESS DEVICE — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, Inc.
- Compress Device — Biomet Orthopedics, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI 50dccf95-c8df-4ea5-b07f-2370ed89f966 35 fields · synced Jun 6, 2026