FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MEDULLARY CANAL SCRAPERS
K Number: K811081
·
Decision Apr 29, 1981
Classifications
1
FEI Numbers
354
Registration Numbers
354
Same Product Code
13
Applicant Total
60
Review Days
8
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Basic Information
- Device Name
- MEDULLARY CANAL SCRAPERS
- K Number
- K811081
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 888.4540
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- The Anspach Effort, Inc.
- Date Received
- April 21, 1981
- Decision Date
- April 29, 1981
- Product Code
- HTO
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HTO | Reamer | FDA class 1 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HTO), ordered by most recent decision date.
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
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SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
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MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
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SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
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FLEXIBLE INTRAMEDULLARY REAMER
FDA 510(k)
FDA Class 1
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COMBINATION REAMER
FDA 510(k)
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·Orthopedic
Other Clearances by The Anspach Effort, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220485 | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) | May 19, 2022 | Substantially Equivalent |
| K183545 | Anspach Helix Dissection Tools | Jul 19, 2019 | Substantially Equivalent |
| K180063 | OCM-G1 Attachment | Mar 27, 2018 | Substantially Equivalent |
| K133604 | ANSPACH EG1 HIGH SPEED SYSTEM, G1 ATTACHMENTS | Jan 10, 2014 | Substantially Equivalent |
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM | Dec 31, 2013 | Substantially Equivalent |
| K113476 | ANSPACH DISSECTION TOOLS | Dec 16, 2011 | Substantially Equivalent |
| K082637 | CRANIAL PERFORATOR | Dec 22, 2008 | Substantially Equivalent |
| K080802 | EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL | Apr 30, 2008 | Substantially Equivalent |
| K061297 | ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM | Jan 26, 2007 | Substantially Equivalent |
| K063688 | SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBE | Jan 16, 2007 | Substantially Equivalent |