# K971208: Medline Industries, Inc. Orthopedic Trays/Kits/Packs

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: May 13, 1997 after 41 days
- Product code: GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid)
- Device class: 2
- Regulation: 21 CFR 878.4493
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baxter Healthcare procedure-specific kits: named in the summary without a submission number
- (no number) Sterile Concepts procedure-specific kits: named in the summary without a submission number

## Indications for use
Medline Orthopedic Trays/Kits/Packs are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer’s original intended use.

Source page: https://510kreport.com/device/K971208
Methodology: https://510kreport.com/methodology