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510(k) K872285

Device
H-H HUNTER ACTIVE TENDON IMPLANT DC
Applicant
HOLTER-HAUSNER INTL.
510(k) number
K872285
Product code
HXA  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1987-09-28
Date received
1987-06-16
Regulation
888.3025
Classification name
Prosthesis, Tendon, Passive
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN R BOLLES
Address
Third And Mill St.S P.O. Box 100 Bridgeport PA US 19405 19405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HXA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243477Universal Tendon SpacerAskorn Medical2025-01-10
K000019SINGLE SIZE TENDON SPACERMedist International2000-03-29
K973385OVAL SHAPESTechnical Products, Inc.1997-12-05
K964359AVANTA ORTHOPAEDICS TENDON SPACERAvanta Orthopaedics, Inc.1997-03-25
K930125PHOENIX BONE SCREWS PBS-TYPE SERIESPhoenix Bioengineering, Inc.1993-12-30
K872284H-H HUNTER ACTIVE TENDON IMPLANT PCHolter-Hausner Intl.1987-09-28
K872293H-H HUNTER ACTIVE TENDON IMPLANT BCHolter-Hausner Intl.1987-09-28
K853438H-H HUNTER ACTIVE TENDON IMPLANTHolter-Hausner Intl.1985-09-30
K781943TENDON ROD MODEL OR41PO3-6Holter-Hausner Intl.1978-12-04
K780320PASSIVE TENDON IMPLANTHolter-Hausner Intl.1978-03-17

Legacy Summary#

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FDA Review#

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