FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIXATE TISSUE BAND
K Number: K112849
·
Decision Oct 27, 2011
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
138
Applicant Total
12
Review Days
28
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Basic Information
- Device Name
- FIXATE TISSUE BAND
- K Number
- K112849
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5880
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Anulex Technologies, Inc.
- Date Received
- September 29, 2011
- Decision Date
- October 27, 2011
- Product Code
- GZB
- Advisory Committee
- Neurology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GZB | Stimulator, Spinal-Cord, Implanted (Pain Relief) | FDA class 2 | Neurology |
Similar 510(k) Clearances
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Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
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Other Clearances by Anulex Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K121356 | MICRO/MINI N-PK(H) BONE ANCHOR | Nov 9, 2012 | Substantially Equivalent |
| K121354 | MICRO/MINI N-PK(F) BONE ANCHOR | Nov 9, 2012 | Substantially Equivalent |
| K113805 | FIXATE TISSUE BAND | Feb 23, 2012 | Substantially Equivalent |
| K113400 | FIXATE TISSUE BAND | Dec 16, 2011 | Substantially Equivalent |
| K111462 | FIXATE TISSUE BAND | Sep 8, 2011 | Substantially Equivalent |
| K100572 | VERSACLOSE, MODEL VC-200-01 | Mar 17, 2010 | Substantially Equivalent |
| K091432 | XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 | Jun 12, 2009 | Substantially Equivalent |
| K082729 | RIMCLOSE BONE ANCHOR | Dec 19, 2008 | Substantially Equivalent |
| K062307 | XCLOSE TISSUE REPAIR SYSTEM, MODEL SRS | Sep 1, 2006 | Substantially Equivalent |
| K061386 | ANCHOR BAND SUTURING SYSTEM, MODEL SR-AB | Jul 5, 2006 | Substantially Equivalent |