Identity
- Trade Name
- ORTHO SOLUTIONS STERILE DRILL BITS FDA UDI
- Generic Name
- Surgical saw blade, oscillating, single-use FDA UDI
- Device Name
- RECIPROCATING BLADE 80.0MM X 1.1MM FDA UDI
- Model / Reference
- OSA11-905 FDA UDI
- Description
- RECIPROCATING BLADE 80.0MM X 1.1MM FDA UDI
Identifiers
- Catalog Number
- OSA11-905 FDA UDI
- Primary DI / UDI-DI
- 05055662935417 FDA UDI
- 510(k) Number
- K102743 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Surgical saw blade, oscillating, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical saw blade, oscillating, single-use
Ortho Solutions Sterile Drill Bits by Ortho Solutions Holdings Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical saw blade, oscillating, single-use.
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- Brasseler USA — Peter Brasseler Holdings, LLC · Class I
- Stablecut® — Zimmer Orthopaedic Surgical Products · Class I
- GLOBAL STEPTECH — DEPUY (IRELAND) · Class I
- MicroAire® — MicroAire Surgical Instruments LLC · Class I
- Stablecut® — Zimmer Orthopaedic Surgical Products · Class I
Cleared under the same submission
K102743 also covers:
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- McKesson — MCKESSON MEDICAL-SURGICAL INC.
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
- ORTHO SOLUTIONS STERILE DRILL BITS — ORTHO SOLUTIONS HOLDINGS LIMITED
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 I | Pending data |
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Manufacturer
- Manufacturer
- Ortho Solutions Holdings Limited
Sources (1)
- FDA UDI bea2ec2e-22c3-4fea-9aac-789102ba853a 36 fields · synced May 31, 2026