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510(k) K781943

Device
TENDON ROD MODEL OR41PO3-6
Applicant
HOLTER-HAUSNER INTL.
510(k) number
K781943
Product code
HXA  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-04
Date received
1978-11-17
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#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K872285H-H HUNTER ACTIVE TENDON IMPLANT DCHolter-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
K780320PASSIVE TENDON IMPLANTHolter-Hausner Intl.1978-03-17

Legacy Summary#

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FDA Review#

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