FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
H-H HUNTER ACTIVE TENDON IMPLANT BC
K Number: K872293
·
Decision Sep 28, 1987
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
10
Applicant Total
42
Review Days
104
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Basic Information
- Device Name
- H-H HUNTER ACTIVE TENDON IMPLANT BC
- K Number
- K872293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3025
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Holter-Hausner Intl.
- Date Received
- June 16, 1987
- Decision Date
- September 28, 1987
- Product Code
- HXA
- 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 |
|---|---|---|---|
| HXA | Prosthesis, Tendon, Passive | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HXA), ordered by most recent decision date.
Universal Tendon Spacer
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SINGLE SIZE TENDON SPACER
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OVAL SHAPES
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AVANTA ORTHOPAEDICS TENDON SPACER
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PHOENIX BONE SCREWS PBS-TYPE SERIES
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H-H HUNTER ACTIVE TENDON IMPLANT DC
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Holter-Hausner Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K875287 | H-H FLUSHING RESERVOIR | Jul 14, 1988 | Substantially Equivalent |
| K874508 | H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG | Jan 19, 1988 | Substantially Equivalent |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Sep 28, 1987 | Substantially Equivalent for Some Indications |
| K871351 | H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP | May 14, 1987 | Substantially Equivalent |
| K870660 | H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS | May 1, 1987 | Substantially Equivalent |
| K865075 | H-H SUBGALEAL TROCAR | Jan 13, 1987 | Substantially Equivalent |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Oct 16, 1985 | Substantially Equivalent |
| K853437 | H-H HUNTER TENDON ROD | Oct 16, 1985 | Substantially Equivalent |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Sep 30, 1985 | Substantially Equivalent for Some Indications |