FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPEED XL
K Number: K133780
·
Decision Mar 19, 2014
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
230
Applicant Total
13
Review Days
97
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Basic Information
- Device Name
- SPEED XL
- K Number
- K133780
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedical Ent., Inc.
- Date Received
- December 12, 2013
- Decision Date
- March 19, 2014
- Product Code
- JDR
- 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 |
|---|---|---|---|
| JDR | Staple, Fixation, Bone | FDA class 2 | Orthopedic |
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Other Clearances by Biomedical Ent., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K133844 | SPEED TRIAD | Apr 7, 2014 | Substantially Equivalent |
| K131640 | SMOOTH OR THREADED METALLIC BONE FASTENER | Oct 16, 2013 | Substantially Equivalent |
| K102107 | OSSTAPLE CHILL | Sep 3, 2010 | Substantially Equivalent |
| K091951 | HAMMERLOCK | Feb 19, 2010 | Substantially Equivalent |
| K023203 | OSSTAPLE | Oct 17, 2002 | Substantially Equivalent |
| 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 |