Identity
- Trade Name
- DISPOSABLE KIT W/ OSSEOTI IMPLANT FDA UDI
- Generic Name
- Orthopaedic bone staple, non-adjustable FDA UDI
- Model / Reference
- 110027853 FDA UDI
Identifiers
- Catalog Number
- 110027853 FDA UDI
- Primary DI / UDI-DI
- 00880304806368 FDA UDI
- 510(k) Number
- K151615 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Orthopaedic bone staple, non-adjustable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 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
Yes
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
MR Conditional FDA UDI
Category: Orthopaedic bone staple, non-adjustable
Disposable Kit W/ Osseoti Implant by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic bone staple, non-adjustable.
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Cleared under the same submission
K151615 also covers:
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — Biomet Orthopedics, Inc.
- DISPOSABLE KIT W/ OSSEOTI IMPLANT — 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 d4814e15-6097-4da0-9655-58045e6c7dc0 36 fields · synced May 30, 2026