Identity
- Trade Name
- OSS SEGMENT ADAPTER TRIAL FDA UDI
- Generic Name
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
- Model / Reference
- 110018648 FDA UDI
Identifiers
- Catalog Number
- 110018648 FDA UDI
- Primary DI / UDI-DI
- 00880304678354 FDA UDI
- 510(k) Number
- K141331 FDA UDI
- FDA Product Code
- KRO FDA UDIJDI FDA UDILPH FDA UDI
- GMDN Term
- Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 FDA UDI888.3350 FDA UDI888.3358 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant-instrument extension adaptor, reusable
Oss Segment Adapter Trial 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
K141331 also covers:
- COMPRESS OSS FACE ADAPTOR TRIAL — Biomet Orthopedics, Inc.
- COMPRESS OSS TAPER ADAPTOR TRIAL — Biomet Orthopedics, Inc.
- MODULAR NAIL 0 DEGREE LOCK COLLAR TRIAL — Biomet Orthopedics, Inc.
- Modular Nail Lock Collar Trial — Biomet Orthopedics, Inc.
- OSS BOWED COLLARED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS BOWED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS BOWED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS BOWED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS BOWED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS BOWED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS BOWED STEM TRIAL — Biomet Orthopedics, Inc.
- OSS CONICAL AUGMENT TRIAL — 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 |
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Manufacturer
- Manufacturer
- Biomet Orthopedics, Inc.
Sources (1)
- FDA UDI cd393b5d-5e9b-439c-9dbc-be1db7203918 36 fields · synced Jun 8, 2026