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510(k) K932853

PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS by Applied Osteo Systems, Inc. — Product Code JEL

K932853 is an FDA 510(k) premarket notification submitted by Applied Osteo Systems, Inc. for the device "PIN HOLDERS, TRANSFIXING PINS, OL WIRES, HALF PINS". The FDA issued a decision of Substantially Equivalent on February 22, 1994. The device falls under product code JEL (Curette, Biopsy, Bronchoscope (Rigid)), a Class II device regulated under 21 CFR 874.4680. Applied Osteo Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1994
Date Received
June 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Curette, Biopsy, Bronchoscope (Rigid)
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Applied Osteo Systems, Inc.

  • K935383 — FEMROD AND FEMROD RECON INSERT (March 21, 1995)
  • K933995 — TRUE/FLEXTM FEMUR RODS, CAPS, SCREWS AND INSTRUMENTATION (January 27, 1995)
  • K944501 — TRUE/FLEX INTRAMEDULLARY ROD END-CAP (November 28, 1994)
  • K941048 — TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (October 3, 1994)
  • K943160 — INTERFERENCE SCREW (September 30, 1994)
  • K934148 — TRUE/FLEX CLAVICLE RODS (February 22, 1994)
  • K931578 — TEXAS SCOTTISH RITE EASY/LOCK FIXATOR (February 22, 1994)
  • K926465 — FEMORAL INTRAMEDULLARY RODS (August 25, 1993)
  • K924656 — TRUE/ FLEX FIBULA RODS (November 24, 1992)
  • K924657 — TRUE/FLEX METATARSAL RODS (November 24, 1992)

FDA data resources