Identity
- Trade Name
- A.L.P.S.CUP REAMER 16MM FDA UDI
- Generic Name
- Medullary canal orthopaedic reamer, rigid FDA UDI
- Model / Reference
- 010000364 FDA UDI
Identifiers
- Catalog Number
- 010000364 FDA UDI
- Primary DI / UDI-DI
- 00887868075582 FDA UDI
- 510(k) Number
- K131670 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Medullary canal orthopaedic reamer, rigid 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Medullary canal orthopaedic reamer, rigid
A.l.p.s.cup Reamer 16mm by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medullary canal orthopaedic reamer, rigid.
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Cleared under the same submission
K131670 also covers:
- A.L.P.S.1ST MTP FUSION PLATE BENDER — Biomet Orthopedics, Inc.
- A.L.P.S.1ST MTP FUSION PLATE LARGE LEFT — Biomet Orthopedics, Inc.
- A.L.P.S.1ST MTP FUSION PLATE LARGE RIGHT — Biomet Orthopedics, Inc.
- A.L.P.S.COMPRESSION WIRE LONG — Biomet Orthopedics, Inc.
- A.L.P.S.COMPRESSION WIRE MEDIUM — Biomet Orthopedics, Inc.
- A.L.P.S.COMPRESSION WIRE SHORT — Biomet Orthopedics, Inc.
- A.L.P.S.CONE REAMER 14MM — Biomet Orthopedics, Inc.
- A.L.P.S.CUP REAMER 14MM — Biomet Orthopedics, Inc.
- A.L.P.S.CUP REAMER 18MM — Biomet Orthopedics, Inc.
- A.L.P.S.INLINE FUSION PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.INLINE FUSION PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.LAPIDUS PLATE — 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 820bc17b-a2e9-497c-ab34-c889c87e6da5 35 fields · synced May 30, 2026