Atlas FDA

UHR UNIVERSAL6HIP REPLACEMENT

FDA 510(k) clearance K800207 · decided 1980-02-11

Clearance details

K-number
K800207
Device name
UHR UNIVERSAL6HIP REPLACEMENT
Applicant
Osteonics Corp.
Decision
Substantially Equivalent
Date received
1980-01-30
Decision date
1980-02-11
Days to decision
12 days
Clearance type
Traditional
Product code
KWL
Device class
2
Regulation number
888.3360
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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UHR Bipolar Implants, Restoration GAP II Implants (K222632)Howmedica Osteonics Corp., Dba Stryker Orthopaedics2022-10-21
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Recalls involving this device

RecordFirmDate
Stryker Orthopaedics, UHR Universal Bipolar Component; 26 x 42 mm, Hip Prosthesis Componen recall (Z-0621-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics UHR Universal Bipolar Component; 26 x 44 mm, Hip Prosthesis Component recall (Z-0622-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 44 mm, Hip Prosthesis Componen recall (Z-0623-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 45 mm, Hip Prosthesis Componen recall (Z-0624-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 45 mm, Hip Prosthesis Componen recall (Z-0625-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 46 mm, Hip Prosthesis Componen recall (Z-0626-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 46 mm, Hip Prosthesis Componen recall (Z-0627-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 43 mm, Hip Prosthesis Componen recall (Z-0628-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 47 mm, Hip Prosthesis Componen recall (Z-0629-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 47 mm, Hip Prosthesis Componen recall (Z-0630-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip Prosthesis Componen recall (Z-0631-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 48 mm, Hip Prosthesis Componen recall (Z-0632-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 49 mm, Hip Prosthesis Componen recall (Z-0633-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 49 mm, Hip Prosthesis Componen recall (Z-0634-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 50 mm, Hip Prosthesis Componen recall (Z-0635-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 50 mm, Hip Prosthesis Componen recall (Z-0636-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 51 mm, Hip Prosthesis Componen recall (Z-0637-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 51 mm, Hip Prosthesis Componen recall (Z-0638-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 52 mm, Hip Prosthesis Componen recall (Z-0639-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 53 mm, Hip Prosthesis Componen recall (Z-0640-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 52 mm, Hip Prosthesis Componen recall (Z-0641-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 53 mm, Hip Prosthesis Componen recall (Z-0642-2008)Stryker Howmedica Osteonics Corp.2008-03-20
UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 54 mm, Hip Prosthesis Componen recall (Z-0643-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 55 mm, Hip Prosthesis Componen recall (Z-0644-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 55 mm, Hip Prosthesis Componen recall (Z-0645-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Componen recall (Z-0646-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 41 mm, Hip Prosthesis Componen recall (Z-0647-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 54 mm, Hip Prosthesis Componen recall (Z-0648-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 56 mm, Hip Prosthesis Componen recall (Z-0649-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 56 mm, Hip Prosthesis Componen recall (Z-0650-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 58 mm, Hip Prosthesis Componen recall (Z-0651-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 61 mm, Hip Prosthesis Componen recall (Z-0652-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 61 mm, Hip Prosthesis Componen recall (Z-0653-2008)Stryker Howmedica Osteonics Corp.2008-03-20
UStryker Orthopaedics; HR Universal Bipolar Component; 26 x 68 mm, Hip Prosthesis Componen recall (Z-0654-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 68 mm, Hip Prosthesis Componen recall (Z-0655-2008)Stryker Howmedica Osteonics Corp.2008-03-20
Stryker Orthopaedics; UHR Universal Bipolar Component; 28 x 72 mm, Hip Prosthesis Componen recall (Z-0656-2008)Stryker Howmedica Osteonics Corp.2008-03-20