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510(k) K770118

CARPENTER BONE CLAMP by Stryker Corp. — Product Code HXD

K770118 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "CARPENTER BONE CLAMP". The FDA issued a decision of Substantially Equivalent on January 26, 1977. The device falls under product code HXD (Clamp), a Class I device regulated under 21 CFR 878.4800. Stryker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1977
Date Received
January 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Stryker Corp.

  • K261481 — Pangea Femur Reconstruction System (June 29, 2026)
  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)
  • K250163 — T2 Alpha Femur Retrograde Nailing System (August 13, 2025)
  • K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pan (October 6, 2024)
  • K233919 — VariAx 2 Distal Radius System (March 25, 2024)
  • K233741 — Hoffmann LRF System (December 21, 2023)
  • K230045 — HipCheck (September 29, 2023)
  • K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with (September 20, 2023)

Other clearances for product code HXD

  • K890381 — PARAMETRIUM CLAMP (February 3, 1989)
  • K890368 — KIDNEY CLAMP (February 3, 1989)
  • K890372 — INTESTINAL CLAMP (February 3, 1989)
  • K890371 — INTESTINAL CRUSHING CLAMP (February 3, 1989)
  • K874959 — VASCULAR CLAMP (December 30, 1987)
  • K872386 — C CLAMP (July 2, 1987)
  • K863653 — SUCTION-OFF (October 7, 1986)
  • K853538 — CANNULA CLAMP (September 12, 1985)
  • K851654 — OMNIMED CLAMP (May 31, 1985)
  • K801819 — SURGICAL INSTRUMENTS (August 20, 1980)

FDA data resources