Identity
- Trade Name
- ELEVATOR, 5mm PERIOSTEAL FDA UDI
- Generic Name
- Periosteal elevator, reusable FDA UDI
- Model / Reference
- 0911-100 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848665030013 FDA UDI
- 510(k) Number
- K161913 FDA UDI
- FDA Product Code
- HWC FDA UDIHRS FDA UDI
- GMDN Term
- Periosteal elevator, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI888.3030 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Periosteal elevator, reusable
ELEVATOR, 5mm PERIOSTEAL by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Periosteal elevator, reusable.
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- BARRIER PLACEMENT INSTRUMENT — W.H. Holden, Inc. · Class I
- ELEVATOR — KLS-Martin L.P. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
Cleared under the same submission
K161913 also covers:
- ELEVATOR, 10mm PERIOSTEAL — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- RETAINING T10 DRIVER, SHORT — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- T10 SCREWDRIVER, SELF RETAINING — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- T15 CANNULATED SCREWDRIVER, SELF RETAINING — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 100mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 10mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 14mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 16mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 18mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 20mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 22mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 24mm — ADVANCED ORTHOPAEDIC SOLUTIONS, 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
- Advanced Orthopaedic Solutions, Inc.
Sources (1)
- FDA UDI 8b97734f-8f7e-44dc-8e3b-e2c80c4717bb 34 fields · synced May 30, 2026