Identity
- Trade Name
- A.L.P.S.MIS TARGETING GUIDE FDA UDI
- Generic Name
- Orthopaedic implant aiming/guiding block, reusable FDA UDI
- Model / Reference
- 110008303 FDA UDI
Identifiers
- Catalog Number
- 110008303 FDA UDI
- Primary DI / UDI-DI
- 00887868076602 FDA UDI
- 510(k) Number
- K132898 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic implant aiming/guiding block, reusable 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: Orthopaedic implant aiming/guiding block, reusable
A.l.p.s.mis Targeting Guide by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant aiming/guiding block, reusable.
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Cleared under the same submission
K132898 also covers:
- A.L.P.S.COBB ELEVATOR W/ MARK — Biomet Orthopedics, Inc.
- A.L.P.S.MESH LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MESH LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MESH LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING CALCANEAL PLATE — Biomet Orthopedics, Inc.
- A.L.P.S.MIS LOCKING DRILL GUIDE — 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 04295cc8-90c4-4a37-ac3d-c802355d7d31 36 fields · synced Jun 8, 2026