← Product Code [KDD](/submissions/SU/subpart-e%E2%80%94surgical-devices/KDD) · K971317

# NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (K971317)

_National Healthcare Mfg. Corp. · KDD · May 8, 1997 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KDD/K971317

## Device Facts

- **Applicant:** National Healthcare Mfg. Corp.
- **Product Code:** [KDD](/submissions/SU/subpart-e%E2%80%94surgical-devices/KDD.md)
- **Decision Date:** May 8, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4800
- **Device Class:** Class 1
- **Review Panel:** General, Plastic Surgery

## Device Story

Orthopedic pack, tray, or kit; intended for use in clinical settings to organize and provide necessary components for orthopedic procedures. Device consists of pre-packaged, sterile or non-sterile instruments and supplies. Facilitates procedural efficiency by consolidating required items for healthcare providers.

## Technological Characteristics

Kit/tray assembly containing various orthopedic instruments and supplies. Sterilization method not specified. No specific materials or software described.

## Regulatory Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

## Submission Summary (Full Text)

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mdi
Attachment 1
510(k) Summary
MAY - 8 1997
K971317

# National Healthcare Manufacturing Corp.
## Orthopedic Kit or Tray

### Submitter Information:

Alice Gibson
General Manager
National Healthcare Manufacturing Corp.
251 Sulteaux Crescent
Winnipeg, Manitoba R3J 3C7
Canada

### 510(k) Summary Prepared by:

Carolann Kotula
Official Correspondent for NHMC
c/o mdi Consultants, Inc.
55 Northern Boulevard
Great Neck, NY 11021

Phone: (516) 482-9001
Fax: (516) 482-0186

### Date 510(k) Summary Prepared: April 1, 1997

### Name/Classification of the Device:

**Classification Name:** A classification name could not be located for these devices.

### Common Name: Orthopedic Pack, Tray, or Kit

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Consulting since 1978

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KDD/K971317](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KDD/K971317)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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