FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SMOOTH OR THREADED METALLIC BONE FASTENER
K Number: K131640
·
Decision Oct 16, 2013
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
13
Review Days
134
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Basic Information
- Device Name
- SMOOTH OR THREADED METALLIC BONE FASTENER
- K Number
- K131640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedical Ent., Inc.
- Date Received
- June 4, 2013
- Decision Date
- October 16, 2013
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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| K091951 | HAMMERLOCK | Feb 19, 2010 | Substantially Equivalent |
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| K001353 | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K001354 | MEMOGRAPH; OSSTAPLE - ORTHOPEDIC USES FOR SMALL BONE AND FRAGMENT FIXATION FOR THE MEMOGRAPH STAPLE SYSTEM | Mar 13, 2001 | Substantially Equivalent |
| K001219 | MEMOGRAPH; OSSTAPLE - ORAL AND MAXILLIOFACIAL PROCEDURES FOR THE MEMOGRAPH STAPLE SYSTEM | Jun 21, 2000 | Substantially Equivalent |
| K993714 | MEMOGRAPH STAPLE, WARM SYSTEM | Feb 25, 2000 | Substantially Equivalent |
| K971782 | BONE AND MARROW COLLECTION SYSTEM KIT | Jul 29, 1997 | Substantially Equivalent |